Self-regulation of brain activity using real-time fMRI for fibromyalgia pain

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

See if real-time fMRI neurofeedback combined with either cognitive behavioral therapy or fibromyalgia education helps adults with fibromyalgia learn to control brain responses and reduce pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07023523 on ClinicalTrials.gov

What this trial studies

This study uses real-time functional MRI neurofeedback to let people with fibromyalgia see and try to change their own brain activity while experiencing experimental pressure pain. Participants complete a baseline MRI session with neurofeedback and pressure stimulation, then are randomized to eight weekly sessions of either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education. A second MRI visit repeats the neurofeedback tasks to measure changes in brain responses and self-regulation strategies. Questionnaires and planned mental strategies are used to guide regulation attempts and to track changes in pain catastrophizing and clinical pain.

Who should consider this trial

Good fit: Adults aged 18–65 with a physician-confirmed diagnosis of fibromyalgia for at least one year, average baseline pain of ≥4/10 on most days, stable medications, fluent in English, and able to undergo MRI are the intended participants.

Not a fit: People who are pregnant or nursing, have MRI contraindications, severe psychiatric illness (including psychosis), uncontrolled anxiety that prevents MRI, comorbid pain conditions rated worse than fibromyalgia, or who cannot keep stable medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could give people with fibromyalgia a non-drug way to reduce pain and lessen pain catastrophizing by teaching them to self-regulate pain-related brain activity.

How similar studies have performed: Related real-time fMRI neurofeedback studies have shown promising but preliminary effects on pain-related brain activity and symptoms, while targeting catastrophizing in fibromyalgia with this method is relatively new.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Athinoula A. Martinos Center for Biomedical Imaging — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Jeungchan Lee, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Soobin Choi, [e-mail]

Conditions Fibromyalgia