Neuroimaging for Chronic Fatigue Syndrome

Overseen By Eric M Wassermann, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must not be taking: Antidepressants, Stimulants, Opioids, others

Disqualifiers: Neurological, Psychiatric, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

47 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eric M Wassermann, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

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.

Inclusion Criteria

Healthy Controls: Ability to understand and sign a written informed consent document

Healthy Controls: Willingness to comply with study procedures and availability for the duration of the study

I am between 18 and 50 years old and healthy.

Exclusion Criteria

I do not have any major neurological or psychiatric disorders.

Healthy Controls: Current major medical disorders

I am currently taking medication that affects my brain or nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-5 weeks

1 visit (in-person)

Mock MRI and Task Practice

Participants undergo a mock MRI scan and practice thermal pain and physical effort tasks

1 visit

1 visit (in-person)

Real MRI and Task Execution

Participants undergo real MRI scans and perform thermal pain and physical effort tasks

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI sessions

1-4 weeks

Treatment Details

Interventions

• Functional Neuroimaging

Trial Overview 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.

Participant Groups

Group I: Single Arm Experimental Treatment 2 Interventions

This is a single-arm study. The order of intervention administration will be counterbalanced within this single arm.

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+