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NCT Number: NCT07023523

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athinoula A. Martinos Center for Biomedical Imaging

Boston, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Soobin Choi

CONTACT

[email protected]

617-952-6742

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Disease Education

Behavioral

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

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Pain Catastrophizing Scale (PCS)

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

    Pain catastrophizing will be assessed with the Pain Catastrophizing Scale (PCS).

    Pain Catastrophizing Scale (PCS) is a validated survey instrument that assesses the extent of catastrophizing thinking related to pain. Pain catastrophizing is assessed on a scale from 0 to 52, with higher scores indicating a higher levels of catastrophizing.

  2. Brief Pain Inventory (BPI)

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

    Brief Pain Inventory (BPI) is a validated questionnaire designed to assess the severity and interference of pain experienced. Pain severity is assessed on a scale from 0 (no pain) to 10 (severe pain). Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).

Other outcomes

  1. Self-regulation performance

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

    During each real-time fMRI self-regulation trial, patients will receive visual feedback of their modulated brain activity, and neurofeedback performance will be measured by their ability to successfully modulate the visual feedback indicator (i.e., increasing/decreasing it as instructed). Changes in performance scores between baseline and post-treatment will be calculated.

  2. Chronic Pain Self-Efficacy Score (CPSS)

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

    Chronic Pain Self-Efficacy Score (CPSS) is a validated survey instrument that assesses an individual's beliefs and confident in their ability to manage and cope with chronic pain. Each item on the instrument is scored on a 10-point Likert Scale, from 10 (very uncertain) to 100 (very certain). Average subscale scores are calculated for each domain: self-efficacy for pain management (PSE), self-efficacy for coping with symptoms (CSE), and self-efficacy for physical function (FSE).

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Spaulding Rehabilitation Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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