Self-regulation of Real-time fMRI Brain Activity in Chronic Pain

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07023523
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy — BEHAVIORAL
    Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
  • Disease Education — BEHAVIORAL
    Providing information about fibromyalgia, including its potential causes and management approaches.

Study Details

This study aims to explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. The study consists of 2 magnetic resonance imaging (MRI) visits that involve brain neuroimaging for fMRI neurofeedback tasks, as well as 8 weekly intervention sessions with a pain psychologist. Patients will be randomized to either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups.

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cognitive Behavioral Therapy
    8 individual weekly visits with a psychologist for pain-related CBT.
  • Active Comparator: Disease Education
    8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).

Primary Outcome Measure

Changes in brain activity in pain-associated regions such as vPCC/RSC [ Time Frame: Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Athinoula A. Martinos Center for Biomedical ImagingBostonMassachusetts02129
Soobin Choi
[email protected]
617-952-6742

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By research site
Athinoula A. Martinos Center for Biomedical Imaging· Boston, MA

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