NCT07023523 · Brigham and Women's Hospital
Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 3, 2025 · Source of record for eligibility and locations