Recruiting

fMRI Neurofeedback

Sponsor:

Brigham and Women's Hospital

Code:

NCT07023523

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Disease Education

Study Details

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

Study ID

NCT07023523

Start date

Oct 31, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 18-65
2. Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
3. On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
4. Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
5. Able to provide written consent and fluent in English

Exclusion Criteria:

1. Comorbid acute pain condition
2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
3. Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
4. Pregnant or nursing
5. Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
6. History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
7. Contraindication to MRI (e.g., implanted ferrous metal)
8. History of significant head injury (e.g., with substantial loss of consciousness)
9. Psychiatric hospitalization in the past 6 months
10. Other contraindications to MRI
11. Participating in other therapeutic trials
12. Active suicidal ideation
13. Documented peripheral neuropathy of known cause (e.g diabetic neuropathy, chemotherapy-induced neuropathy, guillain-barre)
14. Routine or daily use of narcotics or substances of abuse
15. Autoimmune or inflammatory disease (RA, SLE, IBD) that causes pain
16. Lower Limb Vascular Surgery or Current Lower Limb Vascular Dysfunction
17. Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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).

Interventions

Cognitive Behavioral Therapy

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

Disease Education

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

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 and Locations

Central contacts

Soobin Choi, schoi38@mgb.org

617-952-6742schoi38@mgb.org

Locations

Athinoula A. Martinos Center for Biomedical Imaging

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-11-03.