Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
NCT Number: NCT06472622
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Fatigue Syndrome, Chronic
Interventions: DEVICE: Thermal Pain Stimulation|DEVICE: Physical Effort Stimulation
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT
Enrollment: 47
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2034-06-30
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

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.

Primary Outcome Measures: Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain., SVN regions in which activity is significantly associated with unpleasantness of pain., 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.|Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort., The SVN has been hypothesized to play a role in producing the unpleasantness of negative experiences including effort., 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.