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NIH Post-Infectious ME/CFS Study
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==Aims== Doctor [[Avindra Nath]] stated "The relationship of infections to the onset of [[ME/CFS]] and the large body of literature identifying a variety of interesting but inconsistent immune abnormalities in these patients provide a rationale for further studies of immune regulation".<ref name="cdc_grand_rounds_talks">{{Cite web|url=https://www.meaction.net/2016/02/16/transcripts-and-slides-from-dr-naths-talk-on-nih-study/ | title = Transcripts and Slides from Dr Nath's talk on NIH study | date = 2016-02-16 | website = #MEAction|language=en-US|access-date=2020-06-26}}</ref> The study is designed to form three phases: ===Phase 1 - Deep phenotyping=== "To conduct a cross-section study for deep phenotyping of PI-ME/CFS to define its pathophysiology."<ref name="cdc_grand_rounds_talks" /> ====Aim 1 - To define the clinical phenotype==== "...the first aim of this study is to define the clinical phenotyping using in-depth assessments of all domains of the illness".<ref name="cdc_grand_rounds_talks" /> *History and physical examination and systemic assessment *[[Nervous system|Neurological]] assessment *Neurocognitive assessment *[[Mental health|Psychiatric]] evaluation *[[Pain]]/[[headache]] evaluation *[[Infectious disease]] and rheumatologic evaluation by specialists *[[neuroendocrine symptoms|Neuroendocrine]] evaluation *[[Fatigue]] testing, [[Two day exercise test|exercise capacity]] ====Aim 2 - To understand the underlying physiology of fatigue (pre and post-exercise)==== "Aim two of the study is to define the physiological basis of fatigue using [[functional MRI]] scan of the [[brain]] to define the brain circuits that are involved. Do detailed metabolic studies in a metabolic chamber and do [[transcranial magnetic stimulation]] as well as very detailed autonomic testing. Each of these tests will be performed before and after [[exercise]]".<ref name="cdc_grand_rounds_talks" /> *[[Functional MRI]] *[[Metabolic]] studies *[[Transcranial magnetic stimulation]] *[[Autonomic nervous system|Autonomic]] function ====Aim 3 - To determine if there are abnormal immune or microbiome profiles==== "The third aim of this study is to conduct a detailed immunological study in blood as well as cerebrospinal fluid including a screen for autoantibodies to neuro antigens. We will also fully explore the gut and oral microbiome and apply proteomics and metabolomics approaches to the [[cerebrospinal fluid]]."<ref name="cdc_grand_rounds_talks" /> *[[Cytokine]] abd [[chemokine]] profile in [[cerebrospinal fluid]] and [[blood]]; after [[T cell]] stimulation in culture *Flow cytometry *[[B cell]] and [[T cell]] cloning and T cell antigen receptor sequencing *[[:Category:Immunoglobulins|Immunoglobulin]] profile *[[Autoantibody|Autoantibodies]] directed against brain antigens *Cerebrospinal fluid [[proteomics]] and [[metabolomics]] *Gut and oral [[microbiome]] *Serum tryptase *[[virus|Viral]] discovery, antibodies to herpes virus ====Aim 4 - To determine if features can be reproduced in ex-vivo studies==== "The fourth aim of this study will utilize a variety of novel approaches to explore whether cells or serum from patients can be used to experimentally reproduce some of the features of the illness. We will determine if there is an inherent metabolic abnormality in neurons derived from stem cells and culture from these patients and if exposure of spinal fluid will induce the functional abnormalities in these cells. We will also generate humanized mice using blood cells from patients and determine if the clinical phenotype can be reproduced in these animals. If these experimental systems are able to reproduce the clinical or biological abnormalities seen in these patients, it would be a major step towards identifying the cause and the pathophysiology of the illness and for developing a variety of treatment approaches to these patients."<ref name="cdc_grand_rounds_talks" /> *To determine if there are functional or mitochondrial abnormalities and electrophysiological properties in induced pluripotent stem cell (iPS) derived neurons from patients with PI-ME/CFS. *Effect of serum and cerebrospinal fluid on iPS cells and derived neurons. *To determine if cerebrospinal fluid or antibodies injected in brains of rodents or humanized mice generated with cells from PI-ME/CFS patients can lead to fatigue or behavioral abnormalities. ===Phase 2 - Establish biomarkers=== "To validate select biomarkers from Phase 1 in a longitudinal study and establish objective endpoints for an intervention study."<ref name="cdc_grand_rounds_talks" /> ===Phase 3 - Evaluate immunomodulators=== "To conduct an early phase intervention study with an immunomodulatory agent that targets biomarkers found in Phase 2."<ref name="cdc_grand_rounds_talks" />
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