Clinical Trial

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

Recruiting Early Phase 1
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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.
Protocol Amendment History 187 amendments
This ClinicalTrials.gov record has been amended 187 times since 2024-06-24; most recent amendment 2026-05-12.
Status change: Not Yet Recruiting → Recruiting 2024-12-26
Trial Details
NCT Number NCT06472622
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Fatigue Syndrome, Chronic
Enrollment 47 participants
Start Date 2025-04-09
Primary Completion 2034-06-30 (estimated)
Study Completion 2034-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28