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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jul 2026 → Feb 2027
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Record History

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  1. Primary and study completion pushed from Jul 2026 to Feb 2027 Show 4 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Oct 31, 2025
    • Site details revised
    v2
  3. Study First Submitted
  • 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.
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.
Trial Details
NCT Number NCT07023523
Lead Sponsor Brigham and Women's Hospital
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Spaulding Rehabilitation Hospital
Conditions
(from sponsor)		 Fibromyalgia
Related terms Fibromyalgia
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov