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NIH Post-Infectious ME/CFS Study
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==Patient recruitment== <blockquote>"...for the purpose of our phase one study, we plan to recruit patients primarily from well characterized cohorts– particularly the CDC’s M CAM study described earlier by [[Elizabeth Unger|Dr Unger]]. Selection criteria will include documentation of the acute onset and duration of fatiguing illness for more than 6 months but less than five years. All patients will have [[post-exertional malaise]] and full criteria of the [[Fukuda criteria|1994 research case definition]] and the [[Canadian Consensus Criteria]] as mentioned earlier. The study population will include 40 Post infectious ME/CFS patients, 20 healthy controls, 20 [[Chronic lyme disease|Post Lyme Disease]] patients who are asymptomatic – that means they do not have fatigue and 20 patients with [[Functional movement disorder]]s."<ref name="cdc_grand_rounds_talks" /></blockquote> <blockquote>"The eligibility criteria for this study includes four groups of adults that either: 1) have ME/CFS with [[post-exertional malaise]] fulfilling multiple consensus criteria; 2) had [[Lyme disease]], were treated, and don't have fatigue symptoms; 3) have a [[functional movement disorder]]; or 4) are healthy volunteers."<ref name="eligible2016">{{Cite web|url=https://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih | title = Eligibility Requirements for ME/CFS Clinical Study at the NIH | date = 2016-02-13 | website = National Institutes of Health (NIH)|language=EN|access-date=2020-06-26}}</ref></blockquote> === Changes === In March 2016, [[Vicky Whittemore]] confirmed a change to the recruitment criteria, stating "it has been decided that they will not include individuals with [[functional movement disorder]]s in this study".<ref>{{Cite web|url=https://www.meaction.net/2016/03/03/extraordinary-nih-mecfs-study-may-be-most-comprehensive-and-in-depth-ever/ | title = Extraordinary NIH ME/CFS study may be most comprehensive and in-depth ever | date = 2016-03-03 | website = #MEAction|language=en-US|access-date=2020-06-26}}</ref> The initial requirement involving the [[Reeves criteria]] was dropped, and patients would only need to meet the [[Fukuda criteria|Fukuda]] or [[Canadian Consensus Criteria]] - not both - although they must have [[post-exertional malaise]].<ref name="eligible2016" /><ref>{{Cite web|url=https://www.meaction.net/2016/02/09/positive-answers-to-initial-questions-re-nih-clinical-center-protocol/ | title = Positive Answers to Initial Questions re NIH Clinical Center Protocol {{!}} Polly | last = | first = | authorlink = | date = 2016-02-09 | website = #MEAction|language=en-US|archive-url=|archive-date=|access-date=2020-06-26}}</ref><ref name="CTOct2020">{{Cite web | last = National Institute of Neurological Disorders and Stroke | date = 2020-10-03 | title = Myalgic Encephalomyelitis/Chronic Fatigue Syndrome|url=https://clinicaltrials.gov/ct2/show/NCT02669212}}</ref> ===Selection criteria=== *Documentation of acute infectious onset process<ref name="CTSS2020">{{Cite web|url=https://mecfs.ctss.nih.gov/ | title = ME/CFS Clinical Trials Survey System | last = | first = | authorlink = | date = |website=mecfs.ctss.nih.gov|archive-url=|archive-date=|access-date=2020-06-26}}</ref> *ME/CFS with [[post-exertional malaise]]<ref name="CTOct2020" /> *Fatigue more than 6 months but less than 5 years<ref name="CTSS2020" /> *Meet [[Fukuda criteria | 1994 Fukuda criteria]] or the [[Canadian Consensus Criteria]].<ref name="CTOct2020" /> *Ages 18-60 only.<ref name="CTOct2020" />
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