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

Conditions

• Fatigue Syndrome, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Thermal Pain Stimulation — DEVICE
  Thermal pain will be administered during fMRI neuroimaging via a thermal stimulation device (Medoc Ltd., Advanced Medical System, Israel; 510K: K052357; K041908; K922052) to examine brain activity corresponding to the experience of this stimulus. This device and associated system carries an FDA 510 (K) clearance.
• Physical Effort Stimulation — DEVICE
  Physical effort will be administered during fMRI neuroimaging via a hand dynamometer attachment for a physiological monitoring system (BIOPAC Systems, Inc., Goleta, CA, USA) to examine brain activity corresponding to the experience of this stimulus. This device has not received pre-marked approval or 510 (K) clearance by the FDA.

Study Details

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.

Key Dates

Start date

Apr 9, 2025

Status verified

May 2026

Primary completion

Jun 30, 2034

Completion

Jun 30, 2034

Study Design

Enrollment

47 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Other: Single Arm
  This is a single-arm study. The order of intervention administration will be counterbalanced within this single arm.

Primary Outcome Measure

Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain. [ Time Frame: 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. ]

Central Contacts

• Nicholas J Madian, Ph.D.
  (301) 480-9787
  [email protected]
• Eric M Wassermann, M.D.
  (301) 496-0151
  [email protected]

Locations (1)

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