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<h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> » <a href="/research-training">Research & Training</a> » <a href="/research-training/medical-research-initiatives">Medical Research Initiatives</a> » <a href="/research-training/medical-research-initiatives/mecfs">MECFS</a></div> <div class="l-region l-region--section-header">
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<h2><a href="/research-training/medical-research-initiatives/mecfs">Advancing ME/CFS Research</a></h2> </div>
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<p class="publishdate"><span property="dc:date" datatype="xsd:dateTime" content="2020-11-05T10:15:00-05:00" class="date-display-single">November 5, 2020</span></p><h1>Additional QA from the NIH ME/CFS Advocacy Call</h1><p><em>Below are responses to questions that were not answered during the November 5 telebriefing.</em></p>
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<p><strong>What is the National Institutes of Health (NIH) going to do to ensure that myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) funding is greatly increased and is a priority just like COVID? Many people with ME have been suffering for 3 to 4 decades and we should be a main priority as well due to no FDA treatments, no cure including low number of docs that treat and diagnose ME/CFS accurately.</strong></p>
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<p>As part of an effort to stimulate ME/CFS research and expand the field, NIH issued Program Announcements (PARs) for ME/CFS in early 2020. </p>
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<ul>
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<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-165.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em><em>/</em><em>CFS</em>) (R01 Clinical Trials Not Allowed)</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-168.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em><em>/</em><em>CFS</em>) (R21 Clinical Trials Not Allowed)</a></li>
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</ul>
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<p>We hope that the PARs will emphasize our commitment to this disease and encourage many researchers, both inside and outside of the ME/CFS field, to apply for funding.</p>
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<p>It is likely that information that is learned about post-COVID-19 sequelae will benefit our understanding of ME/CFS and can be leveraged to apply to ME/CFS research.</p>
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<p><strong>Given the centrality of ME/CFS research in the era of Long COVID, what is NIH doing to reverse this continuing trend of stagnant ME/CFS funding? Will NIH commit to issuing a request for applications (RFA)?</strong></p>
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<p>As part of an effort to stimulate ME/CFS research and expand the field, NIH issued Program Announcements (PARs) for ME/CFS in early 2020. </p>
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<ul>
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<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-165.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em><em>/</em><em>CFS</em>) (R01 Clinical Trials Not Allowed)</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-168.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em>/<em>CFS</em>) (R21 Clinical Trials Not Allowed)</a></li>
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</ul>
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<p>We hope that the PARs will emphasize our commitment to this disease and encourage many researchers, both inside and outside of the ME/CFS field, to apply for funding.</p>
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<p><strong>Is there any possibility to have some funding especially for the post-COVID cohort showing symptoms of ME/CFS?</strong></p>
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<p>NIH has mobilized quickly to address the pandemic. There are research opportunities available to study long-term effects of COVID-19, investigate how this may progress to ME/CFS, and also how people with ME/CFS are affected by the virus.</p>
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<ul>
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<li><strong>COVID supplements to NINDS grants</strong>: NINDS is open for funding “Urgent Competitive Revisions and Administrative Supplements For Research on Biological Effects of the 2019 Novel Coronavirus on the Nervous System” to current grants (<a href="https://grants.nih.gov/grants/guide/notice-files/not-ns-20-051.html">NOT-NS-20-051</a>) to address the biology, pathophysiology, prevention, diagnosis, sequelae, or treatment of COVID-19 that are directly related to the NINDS mission.</li>
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||
<li>Please visit <a href="https://grants.nih.gov/grants/guide/COVID-Related.cfm">https://grants.nih.gov/grants/guide/COVID-Related.cfm</a> for additional information on NIH funding opportunities related to COVID-19</li>
|
||
<li>Please visit <a href="https://www.niaid.nih.gov/grants-contracts/opportunities?search=COVID">https://www.niaid.nih.gov/grants-contracts/opportunities?search=COVID</a> for additional information on NIAID-specific funding opportunities related to COVID-19</li>
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</ul>
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<p>NIAID staff are coordinating a Trans-NIH Workshop on Post-Acute Sequelae of COVID-19 that will take place on December 3-4, 2020.For more information and to register, go to: <a href="https://cvent.me/MQAxOa" title="https://cvent.me/MQAxOa">https://cvent.me/MQAxOa</a></p>
|
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||
<p><strong>Given the huge importance of investigating ME/CFS in this time period, are you going to issue 1) RFAs for new Collaborative Research Centers (CRCs), and 2) RFAs for stimulating extramural research?</strong></p>
|
||
|
||
<p>As part of an effort to stimulate ME/CFS research and expand the field, NIH issued Program Announcements (PARs) for ME/CFS in early 2020. </p>
|
||
|
||
<ul>
|
||
<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-165.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em><em>/</em><em>CFS</em>) (R01 Clinical Trials Not Allowed)</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-168.html" target="_blank">Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (<em>ME</em>/<em>CFS</em>) (R21 Clinical Trials Not Allowed)</a></li>
|
||
</ul>
|
||
|
||
<p>We hope that the PARs will emphasize our commitment to this disease and encourage many researchers, both inside and outside of the ME/CFS field, to apply for funding.</p>
|
||
|
||
<p><strong>Will RFAs be made available for the renewal of CRCs?</strong></p>
|
||
|
||
<p>The CRCs and the Data Management Coordinating Center (DMCC) are in the fourth year of 5 years of funding. The Trans-NIH ME/CFS Working Group is discussing next steps for research on ME/CFS.</p>
|
||
|
||
<p><strong>Why does the NIH let other people do the heavy lifting? It’s Open Medicine Foundation with FIVE Collaborative Centres. It’s Open Medicine Foundation closest to a diagnostic test - which the NIH won’t fund!!! It’s Open Medicine Foundation already executing a strategic plan. Yet there’s no mention of Open Medicine Foundation at all.</strong></p>
|
||
|
||
<p>The NIH system is open for any scientist, including scientists from the Open Medicine Foundation, to submit their best ideas for research studies on ME/CFS and other diseases. The NIH grant system primarily funds work performed in individual laboratories or clinics by teams of scientists working at academic, medical, and other biomedical research institutions, including industry. Individual investigators interested in pursuing ME/CFS research can submit detailed proposals through their institutions to answer a broad range of research questions. Proposals can be submitted three times per year. Proposed projects undergo a rigorous peer review process at the NIH and are then considered for funding. </p>
|
||
|
||
<p>Researchers from the Open Medicine Foundation have received funding from NIH: <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=10035169&icde=52491810&ddparam=&ddvalue=&ddsub=&cr=1&csb=FY&cs=DESC&pball="></a></p>
|
||
|
||
<ul>
|
||
<li><a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9929524&icde=52491841&ddparam=&ddvalue=&ddsub=&cr=2&csb=FY&cs=DESC&pball=" title="Click to view Project Description">MOLECULAR AND SINGLE-CELL IMMUNOLOGY OF MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME</a> PI: Ron Davis, Stanford University<br />
|
||
<em>**After this page was posted on 12/2/20, it was brought to our attention that two grants included here were not affiliated with OMF and were not related to ME/CFS. The two projects have been removed from the page.</em></li>
|
||
</ul>
|
||
|
||
<p><strong>Can a trial be considered using Ron Davis’s nanoneedle impedance test to assess progression of post COVID-19 toward ME/CFS?</strong></p>
|
||
|
||
<p>The NIH system is open for any scientist to submit his or her best ideas for research studies on ME/CFS and other diseases. Investigators who are considering applying for NIH grants are encouraged to reach out to their program directors. Early contact provides an opportunity for Institute or Center staff to discuss the proposed scope and goals and to provide technical assistance, information, and guidance on the NIH application process.</p>
|
||
|
||
<p><strong>Given how important, and disabling, post-exertional malaise (PEM) is to ME/CFS patients, how can it be ensured that researchers don’t just accept post-exertional fatigue as PEM?</strong></p>
|
||
|
||
<p>The ME/CFS Common Data Elements define PEM, as well as fatigue, as different symptoms.</p>
|
||
|
||
<p><strong>Is anyone studying the progressive subgroup of patients with ME/CFS?</strong></p>
|
||
|
||
<p>Each NIH-funded study outlines the inclusion and exclusion criteria for the study participants that they will enroll in the study. Some of the funded studies may include individuals with progressive disease.</p>
|
||
|
||
<p><strong>Additionally, could the NIH not direct all post-COVID/long-COVID studies that they fund to assess all their participants against ME/CFS criteria to gauge how many more ME/CFS diagnosed folks we might be seeing in the future?</strong></p>
|
||
|
||
<p>NIH cannot require that researchers use specific criteria in their studies. However, we strongly encourage investigators who are conducting ME/CFS-related research to use the <a href="https://www.commondataelements.ninds.nih.gov/Myalgic%20Encephalomyelitis/Chronic%20Fatigue%20Syndrome">ME/CFS Common Data Elements</a>.</p>
|
||
|
||
<p>Although many people who are infected with COVID may go on to experience long-term symptoms, not everyone will develop ME/CFS.</p>
|
||
|
||
<p>One goal of the upcoming workshop is to identify tools or measures that need to be incorporated more broadly in longitudinal studies that are either initiated or expanded from currently designed studies to best study post-acute COVID-19. Many, but certainly not all, current studies have patient-defined outcomes included, but discussion of all the tools needed for a comprehensive study design is an important topic for the workshop participants.</p>
|
||
|
||
<p><strong>What are common diagnostic and treatment approaches to chronic COVID-19 used among clinics in post-acute illness? (expand on post-viral airway/ neuro/immune findings and treatment path)</strong></p>
|
||
|
||
<p>Please refer to current COVID-19 treatment guidelines: <a href="https://www.covid19treatmentguidelines.nih.gov/">https://www.covid19treatmentguidelines.nih.gov</a></p>
|
||
|
||
<p><strong>Dr. Joe Breen stated that one of the stated goals of the upcoming December workshop is to “identify key knowledge gaps that are necessary to address.” A number of long-haulers are reporting experiences of post-exertional malaise, and yet understanding of this debilitating symptom is sparse among researchers and clinicians. For instance, in both the study from Italy and from the MMWR that Dr. Koroshetz presented, post-exertional malaise was not a symptom that was captured. Thank you so much for the recent research article on this topic published in “Frontiers of Neurology.” How do you plan to introduce post-exertional malaise as a key knowledge gap within the context of this workshop?</strong></p>
|
||
|
||
<p>Dr. Nath mentioned during the telebriefing that he was including PEM measures in his post- COVID studies. He will be speaking during the upcoming “Workshop on Post-Acute Sequelae of COVID-19” and participating in the neurological breakout group during the meeting (see: <a href="https://cvent.me/MQAxOa" title="https://cvent.me/MQAxOa">https://cvent.me/MQAxOa</a> for information on the workshop).</p>
|
||
|
||
<p><strong>Has anyone investigated serum or CSF levels of IL-6 or IL-18 in patients with ME/CFS as compared to COVID-19?</strong></p>
|
||
|
||
<p>We don’t know if that has been compared directly, at least yet. The NIAID-funded <a href="https://www.niaid.nih.gov/news-events/niaid-study-examines-immune-responses-people-covid-19">Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) study</a> is deep-immunophenotyping hospitalized COVID-19 patients, and if historical data is available for samples from individuals with ME/CFS, they could be compared.</p>
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<p><strong>Did you see the recent study saying mold is a primary factor in getting COVID</strong>?</p>
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<p>Thanks for noting this.</p>
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<p><strong>Viral immunologists would love to study T-cell response in the post-COVID cohort. I hope soon we could have the opportunity to do that.</strong></p>
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<p>NIAID is supporting many studies in this area using a variety of funding mechanisms. There is intense interest in understanding the role of pre-existing T-cell immunity in COVID-19 as well as in longitudinal studies. All investigators are able to submit grant applications to NIH for proposed studies on COVID-19 using the parent grant announcements (see: <a href="https://grants.nih.gov/grants/guide/parent_announcements.htm">https://grants.nih.gov/grants/guide/parent_announcements.htm</a> )</p>
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<p><strong>Questions to Dr. Nath</strong></p>
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<p><strong>Have any long-COVID patients been added to the NIH intramural study yet?</strong></p>
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<p>None at the moment. We have interviewed eight, brought in two, but all had other underlying explanations for their symptoms.</p>
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<p><strong>Dr. Nath, what does the ‘more targeted‘ investigation of post-COVID ME/CFS look like? What investigations have been dropped?</strong></p>
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<p>We have stopped taking skin biopsies and we will likely not do a lot of the -omic studies that were part of the original protocol since we now know what pathways to look for in our investigations.</p>
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<p><strong>Has anyone performed SPECT scans in brains of ME/CFS and COVID-19 patients to investigate microglia activation in the brain?</strong></p>
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<p>I think you are referring to PET scans. The tracer is not easily available and requires special expertise with placement of arterial line, increasing risk, so these studies have not been done in these study participants.</p>
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<p><strong>Why does it take 3 years to get 25 ME/CFS patients into a study?</strong></p>
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<p>These are not easy studies to do. We screened over 400 potential study participants. When we bring them into the NIH Clinical Center, they are inpatient for over a week, sometimes two weeks, so it takes a long time and a lot of NIH staff to complete each study participant’s protocol. We also brought in about 25 matched controls who undergo similar investigations.</p>
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