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

Recruiting now · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT07023523

Run by

Brigham and Women's Hospital

People needed

36

Starts

2025-10-31

Expected to finish

2026-07-01

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• Lower Limb Vascular Surgery or Current Lower Limb Vascular Dysfunction
• 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 it is running

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

Full record on ClinicalTrials.gov

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