NCT07023523

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pain catastrophizing-a negative cognitive and emotional process that involves helplessness, rumination, and magnification of pain complaints-is the most consistent psychosocial factor predicting deleterious outcomes in chronic musculoskeletal pain, including fibromyalgia. We will use real-time functional magnetic resonance imaging (fMRI) neurofeedback as a research probe to elucidate the neurological mechanisms underlying self-regulation of pain catastrophizing in individuals with fibromyalgia. Investigators will recruit patients diagnosed with fibromyalgia. In the baseline magnetic resonance imaging (MRI) visit, participants will complete a fMRI neurofeedback session inside an MRI scanner. Prior to entering the scanner, participants will complete several questionnaires and discuss with the research team the self-regulation strategies they plan to use during the neurofeedback task to modulate fibromyalgia pain. For the neurofeedback, participants will be presented with a visual representation of their brain activity performance so that they can maintain or update their strategy throughout the run. As part of the baseline visit, investigators will also apply moderate pressure pain to the patient's leg in the scanner to see how their brain responds to the experimental pain stimulation. After the baseline visit, participants will be randomly assigned into the Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups, and they will then attend 8 weekly intervention sessions with a pain psychologist. During the post-intervention MRI visit, participants will complete the same questionnaires and tasks performed at the baseline visit to assess changes in neural mechanisms underlying the self-regulation of fibromyalgia pain and the experience of experimental pain. All outcome measures will be assessed at both baseline and post-intervention visits.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
BEHAVIORAL	Disease Education	Providing information about fibromyalgia, including its potential causes and management approaches.

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-17
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States