nih-gov/heal.nih.gov/funding/awarded?goal=Enhance pain management&page=7
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<select aria-label="Research Focus Area" data-drupal-selector="edit-rfa" id="edit-rfa" name="rfa" class="form-select"><option value="All" selected="selected">Research Focus Area</option><option value="81">Clinical Research in Pain Management</option><option value="40331">Cross-Cutting Research</option><option value="71">Enhanced Outcomes for Infants and Children Exposed to Opioids</option><option value="66">New Strategies to Prevent and Treat Opioid Addiction</option><option value="76">Novel Therapeutic Options for Opioid Use Disorder and Overdose</option><option value="86">Preclinical and Translational Research in Pain Management</option><option value="46831">Training the Next Generation of Researchers in HEAL</option><option value="61">Translation of Research to Practice for the Treatment of Opioid Addiction</option></select>
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<select aria-label="Research Program" data-drupal-selector="edit-research-program" id="edit-research-program" name="research_program" class="form-select"><option value="All" selected="selected">Research Program</option><option value="186">Acute to Chronic Pain Signatures Program</option><option value="136">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</option><option value="42106">Advancing Health Equity in Pain Management </option><option value="161">Back Pain Consortium Research Program</option><option value="106">Behavioral Research to Improve Medication-Based Treatment</option><option value="42126">Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)</option><option value="206">Development and Optimization of Non-Addictive Therapies to Treat Pain</option><option value="151">Development of Novel Immunotherapeutics for Opioid Addiction</option><option value="191">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</option><option value="216">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</option><option value="176">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</option><option value="96">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</option><option value="146">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</option><option value="41416">Harm Reduction Research Network</option><option value="42121">HEAL Data2Action (HD2A)</option><option value="91">HEALing Communities Study</option><option value="141">HEALthy Brain and Child Development (HBCD) Study</option><option value="42146">Improving Delivery of Healthcare Services for Polysubstance Use</option><option value="181">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</option><option value="44116">Integrated Basic and Clinical Team-Based Research in Pain</option><option value="101">Justice Community Overdose Innovation Network (JCOIN)</option><option value="42116">Leveraging Existing and Real-Time Opioid and Pain Management Data</option><option value="42586">Native Collective Research Effort to Enhance Wellness (N CREW) Program: Addressing Overdose, Substance Use, Mental Health, and Pain </option><option value="111">Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions</option><option value="126">Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder</option><option value="44086">Optimizing the Quality, Reach, and Impact of Addiction Services</option><option value="44106">Oral Complications Arising From Pharmacotherapies to Treat Opioid Use Disorders</option><option value="166">Pain Management Effectiveness Research Network (ERN)</option><option value="171">Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)</option><option value="211">Preclinical Screening Platform for Pain</option><option value="116">Preventing Opioid Use Disorder </option><option value="44091">Prevention and Management of Chronic Pain in Rural Populations</option><option value="131">Prevention of Progression to Moderate or Severe Opioid Use Disorder</option><option value="44111">Rapidly Assessing the Public Health Impact of Emerging Opioid Threats</option><option value="39646">Recovery Research Networks</option><option value="39621">Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)</option><option value="42136">Restoring Joint Health and Function to Reduce Pain (RE-JOIN)</option><option value="121">Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery</option><option value="42111">Small Business Programs</option><option value="40256">Stigma in Pain Management and Opioid Use Disorder</option><option value="44096">The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development</option><option value="42151">The Continuum of Care in Hospitalized Patients with Opioid Use Disorder and Infectious Complications of Drug Use (CHOICE)</option><option value="201">Translating Discoveries into Effective Devices to Treat Pain</option><option value="196">Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder</option><option value="44101">Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure</option></select>
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<span id="project-title-34101"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9829475&amp;amp;icde=46542989" target="_blank">1R61NS113315-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Biomarker Signature to Predict the Persistence of Post-Traumatic Headache </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/biomarkers" hreflang="en">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">MAYO CLINIC ARIZONA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CHONG, CATHERINE DANIELA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Scottsdale, AZ </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-041.html" target="_blank">RFA-NS-18-041</a>
<br>
<strong>Summary:</strong>
<br>
<p>There is currently no recognized way of accurately predicting who will recover from post-traumatic headache (PTH) during the acute phase following concussion and who will go on to develop persistent post-traumatic headache (PPTH), a condition that is difficult to treat effectively. Clinical experience suggests that early treatment is most effective, before headache patterns become persistent, but treating all patients with PTH would expose some patients to unnecessary treatment. Clinicians lack the information needed to make informed treatment decisions. Therefore, the study goals are to develop a prognostic biomarker signature for PPTH using clinical data and structural and functional brain neuroimaging and to assess the predictive accuracy of an ensemble biomarker signature for the early identification of patients at high risk for PPTH. This study can be translated into clinical practice and integrated into PTH clinical trials for early identification of those individuals who are at high risk for PPTH.</p>
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<span id="project-title-34181"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9782089&amp;amp;icde=41498028" target="_blank">3R42TR001270-03S1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">PERIPHERAL NERVE-ON-A-CHIP FOR PREDICTIVE PRECLINICAL PHARMACEUTICAL TESTING </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">AXOSIM, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CURLEY, JABE L; MOORE, MICHAEL J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">NEW ORLEANS, LA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2016-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-303.html" target="_blank">PA-16-303</a>
<br>
<strong>Summary:</strong>
<br>
<p>The ability to de-risk lead compounds during pre-clinical development with advanced “organoid-on-a-chip” technologies shows promise. Development of microphysiological models of the peripheral nervous system is lagging. The technology described herein allows for 3D growth of high-density axonal fiber tracts, resembling peripheral nerve anatomy. The use of structural and functional analyses should mean drug-induced neural toxicity will manifest in these measurements in ways that mimic clinical neuropathology. The goals of this proposal are to establish our human model using relevant physiological measurements in tissues fabricated from human iPS cells and to validate the model system with a library of compounds, comparing against conventional cell culture models. Validating the peripheral nerve model system with drugs known to induce toxicity via a range of mechanisms will demonstrate the ability of the system to predict various classifications of neuropathy, yielding a high-content assay far more informative than traditional in vitro systems.</p>
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<span id="project-title-34291"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9868113" target="_blank">1U24NS113847-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Early Phase Pain Investigation Clinical Network: Greater New York Clinical Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NEW YORK UNIVERSITY SCHOOL OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DOAN, LISA (contact); LIPTON, RICHARD B </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-025.html" target="_blank">RFA-NS-19-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>The Greater New York Clinical Center (GNYCC) aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. The consortium comprises four major academic centers in New York City, one of the most diverse cities in the United States and the nations largest metropolitan area. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders, 2) develop a plan for swift evaluation and launch of proposed studies, and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34466"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9755187&amp;amp;icde=41497968" target="_blank">3R01NR015642-04S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">SEVERE PAIN DURING WOUND CARE PROCEDURES: MODEL AND MECHANISMS </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Iowa </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GARDNER, SUE E </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Iowa City, IA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Chronic Wounds: Advancing the Science from Prevention to Healing (R01)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NR-15-001.html" target="_blank">RFA-NR-15-001</a>
<br>
<strong>Summary:</strong>
<br>
<p>Wound care procedures (WCPs), such as dressing changes, cause moderate to severe pain in 74% of patients, nearly half of whom experience severe pain. Mainstay recommendations to prevent pain during WCPs have focused on either administration of preventive and procedural analgesia or use of expensive, non-adherent dressings. However, it is unclear which patients to target for analgesia or expensive dressings, leading to their inappropriate over- or underuse. To achieve the aims of the study, a comprehensive set of wound, patient, and biological factors will be measured concurrently with pain during a dressing change among a sample of 450 inpatients with open wounds. A predictive model will be developed and biological mechanisms will be examined using logistic regression. The proposed study has the potential to make significant contributions because clinicians will be able to target those patients requiring preventive pain control, thereby eliminating the spiraling impact of painful procedures on nociceptor sensitization.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34586"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9992422" target="_blank">3U24TR001579-04S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">TIN Supplement </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/pain-management-research" hreflang="en">Pain Management Effectiveness Research Network (ERN)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Vanderbilt University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Harris, Paul A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Nashville, TN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-15-004.html">RFA-TR-15-004</a>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34636"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9755668&amp;amp;icde=41497930" target="_blank">3R01MD008931-05S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">VIRTUAL PERSPECTIVE-TAKING TO REDUCE RACE AND SES DISPARITIES IN PAIN CARE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIMHD </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Indiana University - Purdue University Indianapolis </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HIRSH, ADAM T </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Indianapolis, IN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> NIMHD Social, Behavioral, Health Services, and Policy Research on Minority Health and Health Disparities (R01)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-MD-13-006.html" target="_blank">RFA-MD-13-006</a>
<br>
<strong>Summary:</strong>
<br>
<p>Previous studies found that African American (AA) and low socioeconomic status (SES) patients are less likely to receive guideline-concordant pain care relative to White and high SES patients. According to research and theory, enhancing clinician perspective-taking is a promising strategy for improving the care of AA and low SES patients. We have developed an innovative methodology that utilizes computer-simulated patients and environments to assess, understand, and remediate pain treatment disparities. Our approach allows for the intervention to be individually tailored to each trainee, thereby enhancing its impact. It also allows for individual trainees to gain exposure to a greater range of racially and socioeconomically diverse patients than can normally be obtained in traditional training settings. We hypothesize that our perspective-taking intervention will increase trainees knowledge of their own biases, enhance trainees empathy toward patients, and reduce trainees anxiety/threat toward patients, and that these changes will reduce pain treatment disparities.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34766"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9932702&amp;icde=48650379&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1U18EB029353-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of a Wireless Endovascular Nerve Stimulator for Treatment of Refractory Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/discoveries-into-devices" hreflang="en">Translating Discoveries into Effective Devices to Treat Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIBIB </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BAYLOR COLLEGE OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KAN, PETER TZE MAN; ROBINSON, JACOB T; SHETH, SUNIL </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Houston, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-EB-18-003.html" target="_blank">RFA-EB-18-003</a>
<br>
<strong>Summary:</strong>
<br>
<p>For patients with neuropathic pain refractory to therapy using small molecules, modulation of specific neural structures in the central or peripheral nervous system can provide effective alternative treatments. While current Food and Drug Administration–approved devices for dorsal root ganglion (DRG) stimulation are safe and effective, there have been an unfortunate number of adverse events associated with pulse generator infections and lead migration. The research team will develop a wireless, millimeter-sized nerve stimulator that can be delivered through the vasculature and stimulate the DRG to alleviate symptoms of neuropathic pain and the associated minimally invasive delivery method. This endovascular nerve stimulation (EVNS) system depends on development and integration of key novel technologies into an endovascular stent. The magnetoelectric transducers and electronic circuits will convert wireless power and data into stimulus patterns that can trigger neural activity in the DRG via miniature electrodes. After chronic demonstration of safety and functionality in large animal models, the team will prepare for regulatory discussions with the FDA. If successful, the EVNS will provide a technology platform for treating other neuropathic pain syndromes. </p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35001"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9899464" target="_blank">1U18EB029251-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">The Injectrode - A Truly Injectable Electrode for Dorsal Root Ganglion Stimulation to Treat Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/discoveries-into-devices" hreflang="en">Translating Discoveries into Effective Devices to Treat Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIBIB </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF WISCONSIN-MADISON </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LUDWIG, KIP A (contact); WEBER, DOUGLAS J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Madison, WI </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-EB-18-003.html" target="_blank">RFA-EB-18-003</a>
<br>
<strong>Summary:</strong>
<br>
<p>While traditional epidural spinal cord stimulation (SCS) for intractable pain has been very efficacious for the patients responsive to it, the success rate has held at approximately 55%. Dorsal root ganglion (DRG) stimulation has shown promise in early trials to provide greater pain relief. Although the decrease in back pain at 3 months was significantly greater in the DRG arm vs. SCS, the adverse event rate related to the device or implant procedure was significantly higher in the DRG arm. Researchers will develop the “Injectrode” system to make the procedure simpler and safer by using an alternative to implantation: using an injectable pre-polymer liquid composite that cures quickly after injection adjacent to the DRG. They will compare an Injectrode-based system with traditional electrode stimulation at the DRG as an alternative to opioid administration. Researchers will perform benchtop characterization and refinement as a precursor to a clinical study, use modeling and animal testing to refine the efficiency of energy transfer from a transcutaneous electrical nerve stimulation unit to an Injectrode/Injectrode collector concept, and optimize the procedure for the complex anatomy of the human DRG.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35106"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9706434&amp;amp;icde=41497946" target="_blank">3R01MD010372-03S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">PROSPECTIVE STUDY OF RACIAL AND ETHNIC DISPARITIES IN CHRONIC PAIN AND PAIN BURDEN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIMHD </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Rand Corporation </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MARSHALL, GRANT </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Santa Monica, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Mechanisms, Models, Measurement, &amp; Management in Pain Research (R01)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-13-118.html" target="_blank">PA-13-118</a>
<br>
<strong>Summary:</strong>
<br>
<p>Data suggest that members of minority groups are more likely to develop chronic pain and to have greater pain burden. We will identify a set of promising intervention targets for reducing or eliminating racial/ethnic pain disparities. We will interview adult survivors of serious physical injury, comprised of roughly equal proportions of African-Americans (AA), Latinos, and non-Latino Whites (NLW), and examine their medical records for information on injury severity and medication use in-hospital. Our aims are to determine whether: 1) AA and Latino physical injury survivors experience more severe pain relative to NLW; 2) AA and Latino injury survivors experience greater pain burden relative to NLW counterparts; 3) differences in pain severity burden are linked to a set of target candidates for interventions; and (4) pain outcomes in at-risk minority groups can be linked to a set of target candidates for group-tailored interventions to reduce pain severity and pain burden.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35196"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9883576" target="_blank">1UG3TR003150-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Human Microphysiological Model of Afferent Nociceptive Signaling </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/novel-drugs-screening-platforms" hreflang="en">Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">TULANE UNIVERSITY OF LOUISIANA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MOORE, MICHAEL J (contact); ASHTON, RANDOLPH S; RAJARAMAN, SWAMINATHAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New Orleans, LA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Tissue Chips to Model Nociception, Addiction, and Overdose (UG3/UH3 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-19-003.html" target="_blank">RFA-TR-19-003</a>
<br>
<strong>Summary:</strong>
<br>
<p>This project will develop a human cell-based model of the afferent pain pathway in the dorsal horn of the spinal cord. The research teams approach utilizes novel human pluripotent stem cell (hPSC)-derived phenotypes in a model that combines 3D organoid culture with microfabricated systems on an integrated, three-dimensional (3D) microelectrode array. Researchers will establish the feasibility of a physiologically relevant, human 3D model of the afferent pain pathway that will be useful for evaluation of candidate analgesic drugs. They will then improve the physiological relevance of the system by promoting neural network maturation before demonstrating the systems utility in modeling adverse effects of opioids and screening compounds to validate the model. Completion of the study objective will establish novel protocols for deriving dorsal horn neurons from hPSCs and create the first human microphysiological model of the spinal cord dorsal horn afferent sensory pathway.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35341"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9761676&amp;amp;icde=41497995" target="_blank">3R01NS098826-02S1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">PROTEASE ACTIVATED RECEPTOR TYPE 2 TARGETING FOR MIGRAINE PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF TEXAS DALLAS </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PRICE, THEODORE J; BOITANO, SCOTT; DUSSOR, GREGORY O; VAGNER, JOSEF </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">RICHARDSON, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<tr id="summary11" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/pa-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>Migraine is the most common neurological disorder. Currently available treatments fail to effectively manage migraine in most patients. Development of new therapeutics has been slow due in large part to a poor understanding of the underlying pathology of migraine. Endogenous proteases, released in the meninges by resident mast cells, have been proposed as a potential driver of migraine pain via an action on protease activated receptor type 2 (PAR2). The central hypothesis is that PAR2 expression in nociceptors that project to the meninges plays a key role in the pathogenesis of migraine pain. The aims are to: 1) use the established PAR2 development pipeline to design new PAR2 antagonists with improved drug-like properties; 2) use pharmacological tools in a novel mouse migraine model to further understand the potential role of PAR2 in migraine; and 3) use mouse genetics to study the cell typespecific role of PAR2 in migraine pain.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35436"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9957953" target="_blank">1UG3NS116218-01</a>
</span>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Novel mGlu5 negative allosteric modulators as first-in-class non-addictive analgesic therapeutics </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/optimization-non-addictive-therapies" hreflang="en">Development and Optimization of Non-Addictive Therapies to Treat Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">VANDERBILT UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROOK, JERRI MICHELLE; CONN, P JEFFREY; GEREAU, ROBERT W; LINDSLEY, CRAIG </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Nashville, TN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-010.html" target="_blank">RFA-NS-19-010</a>
<br>
<strong>Summary:</strong>
<br>
<p>An extensive literature provides compelling evidence that selective antagonists or negative allosteric modulators (NAMs) of the metabotropic glutamate (mGlu) receptor, mGlu5, have exciting potential as a novel approach for treatment of multiple pain conditions that could provide sustained antinociceptive activity without the serious adverse effects and abuse liability associated with opioids. Researchers have developed a novel series of highly selective mGlu5 NAMs that are structurally unrelated to previous compounds, have properties for further development, and avoid the formation of toxic metabolites that were associated with previous mGlu5 NAMs. Based on existing preclinical models, as well as clinical trial data showing efficacy of an mGlu5 NAM in migraine patients, researchers anticipate that their compounds will have broad-spectrum analgesic activity in patients with a variety of chronic pain conditions.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35596"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9893381" target="_blank">1UG3AT010739-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/prism" hreflang="en">Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCCIH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">KAISER FOUNDATION RESEARCH INSTITUTE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SHERMAN, KAREN J (contact); DEBAR, LYNN L </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Oakland, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AT-19-005.html" target="_blank">RFA-AT-19-005</a>
<br>
<strong>Summary:</strong>
<br>
<p>Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35701"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9881202" target="_blank">1UG3AR076573-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/back-pain" hreflang="en">Back Pain Consortium Research Program</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIAMS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CEDARS-SINAI MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SPIEGEL, BRENNAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Los Angeles, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-029.html" target="_blank">RFA-AR-19-029</a>
<br>
<strong>Summary:</strong>
<br>
<p>Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for musculoskeletal pain, including chronic low back pain (cLBP). Users of VR wear a pair of goggles with a close-proximity stereoscopic screen that creates a sensation of being transported into lifelike, three-dimensional worlds. By stimulating the visual cortex while engaging other senses, VR modulates the user’s processing of nociceptive stimuli. Functional magnetic resonance imaging (fMRI) of the brain reveals that VR has similar effects on the sensory and insular cortex as opioids, and head-to-head trials show that VR achieves similar or greater analgesia as hydromorphone. Since there are few data regarding long-term efficacy and safety of VR in cLBP, this study will measure patient-reported outcomes, biometric outcomes, and opioid use in nonspecific cLBP patients under various experimental conditions using VR therapy.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35886"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9828246&amp;amp;icde=46454612" target="_blank">1R21NS113335-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Targeting the Vgf signaling system for new chronic pain treatments </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/novel-targets" hreflang="en">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Minnesota </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VULCHANOVA, LYUDMILA H </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Minneapolis, MN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-042.html" target="_blank">RFA-NS-18-042</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain is maintained, in part, by persistent changes in sensory neurons, including a pathological increase in peptides derived from the neurosecretory protein VGF (non-acronymic). Preliminary findings show that the C-terminal VGF peptide, TLQP-62, contributes to spinal cord neuroplasticity and that TLQP-62 immunoneutralization attenuates established mechanical hypersensitivity in a traumatic nerve injury model of neuropathic pain. This project will test the hypothesis that spinal cord TLQP-62 signaling can be targeted for the development of new chronic pain treatments through immunoneutralization and/or receptor inhibition. It will pursue discovery and validation of TLQP-62-based therapeutic interventions along two parallel lines: identification of TLQP-62 receptor(s) and validation of anti-TLQP-62 antibodies as a potential biological therapeutic option for chronic neuropathic pain conditions.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-36061"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9622261&amp;amp;icde=41497838" target="_blank">2R44NS086343-04</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">IND-ENABLING STUDIES ON NOVEL CAV3 T-CHANNEL MODULATORS FOR TREATMENT OF NEUROPATHIC PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">AFASCI, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">XIE, XINMIN SIMON </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">REDWOOD CITY, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-17-480.html" target="_blank">PAR-17-480</a>
<br>
<strong>Summary:</strong>
<br>
<p>We discovered a class of non-opioid modulators of the T-type Cav3.2 channel that could treat neuropathic pain. In vivo pharmacokinetic and pharmacodynamic studies and preliminary toxicological studies identified AFA-279 and other candidates, which did not produce observable side-effects and showed greater analgesic effects than other neuropathic pain medications in rodent models. The goal of this proposed project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). We will produce AFA-279 under Good Manufacturing Practice (GMP)like conditions using chemical manufacturing controls for Good Laboratory Practice (GLP) nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, complete toxicological and safety studies to establish the safety profile of AFA-279, prepare and submit the IND application, and then initiate early clinical trials. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33776"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9621475" target="_blank">1R43NR017575-01A1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">COGNIFISENSE, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Sunnyvale, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-17-302.html" target="_blank">PA-17-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33926"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9897908" target="_blank">1UH2AR076723-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Wearable nanocomposite sensor system for diagnosing mechanical sources of low back pain and guiding rehabilitation </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/back-pain" hreflang="en">Back Pain Consortium Research Program</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIAMS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BRIGHAM YOUNG UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BOWDEN, ANTON E </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Provo, UT </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-028.html" target="_blank">RFA-AR-19-028</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic low back pain (cLBP) is recurrent and often nonresponsive to conservative treatments. Biomechanists, physical therapists, and surgeons each utilize a variety of tools and techniques to assess and interpret qualitative movement changes to understand potential mechanical and neurological sources of low back pain and as critical elements in their treatment paradigm. However, objectively characterizing and communicating this information is currently impossible, since clinically feasible (i.e., cost-effective, objective, and accurate) tools and quantitative benchmarks do not exist. This research addresses the challenge to improve cLBP outcomes through the use of unique, inexpensive, screen-printable, elastomer-based, nanocomposite, piezoresponsive sensors, which will be integrated into a SPInal Nanosensor Environment (SPINE) sense system to measure lumbar kinematics and provide an objective, quantitative platform for diagnosis, monitoring, and follow-up assessment of cLBP.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34061"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9902582" target="_blank">1U01DK123821-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/hemodialysis" hreflang="en">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDDK </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">VANDERBILT UNIVERSITY MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CAVANAUGH, KERRI (contact); EDWARDS, DAVID ALLAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Nashville, TN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-18-030.html" target="_blank">RFA-DK-18-030</a>
<br>
<strong>Summary:</strong>
<br>
<p>This study will collaborate with diverse stakeholders to design and conduct a multisite trial evaluating innovative strategies to reduce opioid dosing and improve quality of life and experience with care specific to pain management among adults receiving in-center hemodialysis. A pragmatic parallel arm trial will test the impact of adding a 12-week interactive video cognitive behavioral therapy (IV-CBT) intervention program, compared with CDC guideline-concordant shared decision-making (SDM) for NCCP pharmacotherapy management. The specific aims are to (1) conduct a multisite randomized trial to receive IV-CBT and SDM versus SDM alone over 15 months; (2) investigate and describe barriers and facilitators of the implementation of IV-CBT and also SDM among patients, clinicians, and dialysis staff; and (3) create a collaborative network of investigators and dialysis facilities for efficient recruitment and for dissemination of successful strategies to optimize pain care in dialysis.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34116"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9745568&amp;icde=48649991&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">5R01DA038645-05</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">KOR AGONIST FUNCTIONAL SELECTIVITY IN PERIPHERAL SENSORY NEURONS </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/novel-targets" hreflang="en">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF TEXAS HLTH SCIENCE CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CLARKE, WILLIAM P; BERG, KELLY ANN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">SAN ANTONIO, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary20" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/pa-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>Functional selectivity is a term used to describe the ability of drugs to differentially regulate the activity of multiple signaling cascades coupled to the receptor. The underlying mechanism for functional selectivity is based upon the formation of ligand-specific receptor conformations that are dependent upon ligand structure. Functional selectivity has the potential to revitalize the drug discovery/development process. Ligands with high efficacy for specific signaling pathways (or specific patterns of signaling) that mediate beneficial effects, and with minimal activity at pathways that lead to adverse effects, are expected to have improved therapeutic efficacy. We propose to demonstrate that ligand efficacy for specific signaling pathways associated with antinociception can be finely tuned by structural modifications to a ligand. We propose to use U50,488 and Salvinorin-A (Sal-A) as scaffolds to develop functionally selective analogs that maintain high efficacy for signaling pathways that lead to antinociception and minimize activity toward anti-antinociceptive signaling pathways.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34226"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9869480&amp;icde=48650183&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1UG3AG067493-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/pain-management-research" hreflang="en">Pain Management Effectiveness Research Network (ERN)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">KAISER FOUNDATION RESEARCH INSTITUTE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DEBAR, LYNN L </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Oakland, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary21" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-021.html" target="_blank">RFA-NS-19-021</a>
<br>
<strong>Summary:</strong>
<br>
<p>To enhance availability of cognitive behavioral therapy for chronic pain (CBT-CP), this study will 1) refine strategies to identify and recruit patients, finalize intervention procedures, and ensure data infrastructure and quality; 2) determine the effectiveness of online and telephonic CBT-CP on patients and pain severity and secondary outcomes, including depression, sleep, quality of life, and pain-related health care utilization, from the electronic health record; and 3) assess the cost and incremental cost-effectiveness of online and telephonic CBT-CP compared with usual care. Eligible participants will be randomized to one of two painTRAINER interventions or usual care. Interventions will be eight weekly 45-minute sessions of the online program or telehealth-style phone coaching by trained behavioral health specialists. Self-reported pain severity and secondary outcomes will be assessed at baseline and at three, six, and 12 months.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34381"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9940239" target="_blank">1U24NS115691-01</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF PENNSYLVANIA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">FARRAR, JOHN T (contact); ASHBURN, MICHAEL ALAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Philadelphia, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary22" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-036.html" target="_blank">RFA-NS-19-036</a>
<br>
<strong>Summary:</strong>
<br>
<p>EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a hub and five additional centers that are part of the UPenn Health System and the Childrens Hospital of Philadelphia (CHOP) as spokes, studies will be conducted as designed by the expertise of the EPPIC Network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. The UPenn Specialized Clinical Center (SCC) will test novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34511"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9868758&amp;icde=48649979&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1RF1NS113840-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Nrf2 Activation for Addiction-Free Treatment of Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/novel-targets" hreflang="en">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF TX MD ANDERSON CAN CTR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GRACE, PETER MICHAEL </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Houston, TX </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary23" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-043.html" target="_blank">RFA-NS-18-043</a>
<br>
<strong>Summary:</strong>
<br>
<p>Effective treatments are elusive for the majority of patients with neuropathic pain. Reactive oxygen and nitrogen species (ROS/RNS) are involved in neuropathic pain, because they drive mitochondrial dysfunction, cytokine production, and neuronal hyperexcitability; therefore, stimulation of endogenous antioxidants is predicted to simultaneously resolve multiple neuropathic pain mechanisms. Nuclear factor erythroid 2-related factor 2 (Nrf2) is a transcription factor that is a potential therapeutic target because it regulates the expression of a large number of endogenous antioxidant-related genes and can be activated with a single drug. This project will test the hypothesis that Nrf2 activation increases multiple endogenous antioxidants, therefore reversing neuropathic pain behaviors and counteracting neuropathic pain mechanisms that are driven by ROS/RNS and could provide an effective pain therapy, with minimal abuse/addictive potential.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34601"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9932691&amp;icde=48650377&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1U18EB029354-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Treating pain in sickle cell disease by means of focused ultrasound neuromodulation </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/preclinical-translational/discoveries-into-devices" hreflang="en">Translating Discoveries into Effective Devices to Treat Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIBIB </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CARNEGIE-MELLON UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HE, BIN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pittsburgh, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary24" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-EB-18-003.html" target="_blank">RFA-EB-18-003</a>
<br>
<strong>Summary:</strong>
<br>
<p>Researchers will develop a novel transcranial focused ultrasound (tFUS) device for pain treatment and establish its effectiveness for treating sickle cell disease (SCD) pain in humanized mice. The tFUS will target the specific cortical regions involved in SCD pain using a novel non-invasive electrophysiological source imaging technique. The project’s goals have several aims. Aim 1: Develop tFUS devices for pain treatment. The mouse-scale system will be designed to validate the therapeutic effect of stimulating the anticipated cortical targets. This will inform development of the simpler human-scale system, which will use models of the skull to select cost-effective transducers to reach the targets. Aim 2: Evaluate tFUS effectiveness and optimize stimulation parameters in an SCD mice model. Researchers will determine effective tFUS parameters to chronically reduce SCD pain in mice and validate this using behavioral measures. Aim 3: Use electrophysiological source imaging to target and trigger closed-loop tFUS in animal models. This aim also includes performing safety studies to prepare for human trials. The project will develop a transformative, noninvasive tFUS device to effectively and safely treat pain in SCD. </p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34721"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9908492" target="_blank">1R43DE029369-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">LAUNCHPAD MEDICAL, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">JADIA, RAHUL; KAY, GEORGE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary25" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.</p>
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