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Neuroimaging for Chronic Fatigue Syndrome
Phase < 1
Waitlist Available
Led By Eric M Wassermann, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy Controls: Male or female, aged 18-50
ME/CFS Patients: Male or female, aged 18-50
Must not have
Healthy Controls: Current major neurological or psychiatric disorders
Healthy Controls: Current use of medications acting primarily on the central nervous system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the measurement will be assessed concurrently with physical effort stimulus administration during the fmri associated with one of the study visits, 1-31 days following the visit for the first session.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how the brain processes different unpleasant sensations in people with chronic pain conditions like ME/CFS. Participants will undergo three visits where they will experience mild heat and physical exertion tasks while
Who is the study for?
This trial is for people aged 18 to 50 who have ME/CFS or are healthy volunteers. It involves three visits over a few weeks, where participants will undergo MRI scans and perform tasks that measure their response to pain from heat and the effort of squeezing a bar.
What is being tested?
The study aims to understand how the brain processes unpleasant sensations like pain from mild to moderate heat (thermal pain) and physical exertion (effort). Participants' responses during these activities will be monitored through MRI scans and muscle function tests.
What are the potential side effects?
There may not be direct side effects from participating in this trial as it does not involve medication or invasive procedures. However, some individuals might find lying still in an MRI scanner uncomfortable or experience discomfort from the thermal pain stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old and healthy.
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I am between 18 and 50 years old and have ME/CFS.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any major neurological or psychiatric disorders.
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I am currently taking medication that affects my brain or nerves.
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I have ME/CFS without other major medical conditions.
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I do not have conditions affecting my grip or limbs.
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I have ME/CFS but no major neurological or psychiatric conditions.
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I am currently taking medication for attention, psychosis, or anxiety.
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I have used opioids for more than two weeks in the past two years or recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the measurement will be assessed concurrently with physical effort stimulus administration during the fmri associated with one of the study visits, 1-31 days following the visit for the first session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the measurement will be assessed concurrently with physical effort stimulus administration during the fmri associated with one of the study visits, 1-31 days following the visit for the first session.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
This is a single-arm study. The order of intervention administration will be counterbalanced within this single arm.
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,381 Previous Clinical Trials
652,203 Total Patients Enrolled
Eric M Wassermann, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
17 Previous Clinical Trials
1,795 Total Patients Enrolled