Self-regulation of Real-time fMRI Brain Activity in Chronic Pain: A Potential Neurobiological Mechanism of Cognitive Behavioral Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Aged 18-65

• Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year

• On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial

• Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days

• Able to provide written consent and fluent in English

Locations
United States
Massachusetts
Athinoula A. Martinos Center for Biomedical Imaging
RECRUITING
Boston
Contact Information
Primary
Soobin Choi, schoi38@mgb.org
schoi38@mgb.org
617-952-6742
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2026-07
Participants
Target number of participants: 36
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Spaulding Rehabilitation Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov