Actively Recruiting

Early Phase 1
Age: 18Years - 50Years
All Genders
NCT06472622

Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-13

47

Participants Needed

1

Research Sites

481 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willingness to sign informed consent
  • Willingness to comply with study procedures and be available for the study duration
  • Male or female aged 18 to 50 years inclusive
  • Good general health for healthy volunteers
  • Diagnosis of ME/CFS meeting at least one established criteria for ME/CFS patients
Not Eligible

You will not qualify if you...

  • Current major neurological or psychiatric disorders other than ME/CFS
  • Other major medical disorders that increase risk or affect study participation
  • Use of medications acting on the central nervous system or psychomotor stimulants
  • Opioid use over two weeks in 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
  • More than occasional cannabis use or any illicit drug use or misuse of prescription drugs
  • Conditions affecting grip or extremities that alter sensitivity to painful thermal stimuli
  • Contraindications to MRI including metal implants, pacemakers, claustrophobia, pregnancy or plans to become pregnant
  • Membership in NINDS BNU or their family members
  • Non-English speakers due to lack of validated study instrument translations

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

N

Nicholas J Madian, Ph.D.

CONTACT

E

Eric M Wassermann, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort | DecenTrialz