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

NCT07023523 | Recruiting DMC

• 1 other identifier: R21AR084246
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Changes in brain activity in pain-associated regions such as vPCC/RSC

  Changes in brain activity in pain-associated regions such as vPCC (ventral posterior cingulate cortex)/RSC (retrosplenial cortex), quantified as z-scores, during the self-regulation period of the MRI scan.

  Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months.

Secondary Outcomes (2)

• Pain Catastrophizing Scale (PCS)

  PCS will be assessed at baseline and at post-treatment, spanning approximately 4 months.

• Brief Pain Inventory (BPI)

  BPI will be assessed at baseline and at post-treatment, spanning approximately 4 months.

Other Outcomes (2)

• Self-regulation performance

  Self-regulation performance will be assessed at baseline and at post-treatment, spanning approximately 4 months.

• Chronic Pain Self-Efficacy Score (CPSS)

  CPSS will be assessed at baseline and at post-treatment, spanning approximately 4 months.

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

8 individual weekly visits with a psychologist for pain-related CBT.

Behavioral: Cognitive Behavioral Therapy

Disease Education

ACTIVE COMPARATOR

8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact).

Behavioral: Disease Education

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.

Cognitive Behavioral Therapy

Disease Education BEHAVIORAL

Providing information about fibromyalgia, including its potential causes and management approaches.

Disease Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Comorbid acute pain condition
• Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
• Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
• Pregnant or nursing
• Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
• History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
• Contraindication to MRI (e.g., implanted ferrous metal)
• History of significant head injury (e.g., with substantial loss of consciousness)
• Psychiatric hospitalization in the past 6 months
• Other contraindications to MRI
• Participating in other therapeutic trials
• Active suicidal ideation
• Documented peripheral neuropathy of known cause (e.g diabetic neuropathy, chemotherapy-induced neuropathy, guillain-barre)
• Routine or daily use of narcotics or substances of abuse
• Autoimmune or inflammatory disease (RA, SLE, IBD) that causes pain

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Athinoula A. Martinos Center for Biomedical Imaging

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jeungchan Lee, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soobin Choi, schoi38@mgb.org

CONTACT

617-952-6742; schoi38@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 17, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)