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MinorEligibility criteria expanded, about 33 words
Minor7 versionsRe-verified since Apr 11, 2025, no change to tracked fieldsv184-v190
MinorStart date changed from estimate of Apr 15, 2025 to Apr 9, 2025v183
MinorStart date: Apr 13, 2025 to Apr 15, 2025v182
MinorStart date: Apr 10, 2025 to Apr 13, 2025v181
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MinorStart date: Apr 9, 2025 to Apr 10, 2025v180
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MinorStart date: Feb 13, 2025 to Feb 16, 2025v142
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.