Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort (NCT06472622) | Clinical Trial Compass
RecruitingEarly Phase 1
Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
United States47 participantsStarted 2025-04-09
Plain-language 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 can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability of subject to understand and the willingness to sign a written informed consent document.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged 18-50 (inclusive).
. Good general health as evidenced by medical history and/or physical examination.
. Ability of subject to understand and the willingness to sign a written informed consent document.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged 18-50 (inclusive).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.
Timeframe: The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session.
2
Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.
Timeframe: 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.
Trial details
NCT IDNCT06472622
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
. Has a diagnosis of ME/CFS, meeting at least one of three ME/CFS criteria: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or the Institute of Medicine Diagnostic Criteria.
Exclusion criteria
. Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson s disease, Alzheimer s disease, schizophrenia, or major depressive disorder.
. Any other current major medical disorder, such as a kidney disease, liver disease, cardiovascular disease, chronic pain condition, or any other disorder which, in the opinion of the PI would make participation risky for the individual or negatively affect the individual s ability to cooperate with study procedures.
. Current use of medications acting primarily on the central nervous system, such as antidepressants, stimulants, etc.
. Use of opioid medications for more than two weeks within the last two years or any use in the last month.
. Current or history of substance use disorder, binge drinking, illegal drug use, or excessive tobacco use (defined as more than 10 cigarettes of nicotine per week).
. Any more than occasional use of cannabis, defined as a score \>1 (indicating use on more than one or two days in the last two weeks) on the marijuana use item of the DSM-5 Level 2-Substance Use-Adult questionnaire.
. Any use of other illicit drugs or misuse of prescription medications, defined as a score \>0 on any of the other items of the DSM-5 Level 2-Substance Use-Adult questionnaire.