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Single Arm 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
1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
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

Summary

Background: The way the brain processes rewards and punishments may play a role in some disorders of the nervous system. People with chronic overlapping pain conditions (such as myalgic encephalomyelitis/chronic fatigue syndrome \[ME/CFS\]) may have heightened responses to unpleasant, punishing sensations. Some of these conditions may also cause heightened responses to effort; this is an unpleasant sensation felt during physical and mental exertion. Objective: To learn more about how the brain processes different unpleasant sensations. Eligibility: People aged 18 to 50 years with ME/CFS. Healthy volunteers are also needed. Design: Participants will have 3 visits in 1 to 5 weeks. Visit 1: Participants may have a neurologic exam. They will have a mock magnetic resonance imaging (MRI) scan. They will lie on a bed in a wooden tube while they practice 2 tasks: Thermal pain rating: A device that creates mild to moderate heat will be placed on one leg. Physical effort rating: Participants will squeeze a plastic bar with different levels of force. Visit 2: Participants will have a real MRI scan. They will lie on a table that slides into a large tube. Visit 3: Participants will have another MRI scan. They will repeat the thermal pain and physical effort tasks while in the scanner. Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar. Their heart rate will be tested: They will hold their finger against a camera lens for 1 minute. They will do 2 other tasks: 1 requires repeatedly pressing a key on a keyboard, and the other requires squeezing a bar.

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 below

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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.

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.

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,359 Previous Clinical Trials
650,887 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
~31 spots leftby Jun 2034