Actively Recruiting
Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
Led by Brigham and Women's Hospital · Updated on 2025-11-03
36
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65 years
- Meet Wolfe et al 2011 research criteria for fibromyalgia for at least one year
- On stable medication doses before study entry and agree not to change medications or complementary treatments during the trial
- Baseline average pain intensity of at least 4/10 and pain present on at least 50% of days
- Able to provide written consent and fluent in English
You will not qualify if you...
- Presence of acute pain condition alongside fibromyalgia
- Chronic pain condition more painful than fibromyalgia
- Use of stimulant medications for fatigue related to sleep apnea or shift work (e.g., modafinil)
- Pregnant or nursing
- History of psychotic psychiatric disorders (e.g., schizophrenia, severe personality disorders)
- History of anxiety disorders or anxiety symptoms interfering with MRI procedures (e.g., panic attacks)
- Contraindications to MRI (e.g., implanted ferrous metal)
- History of significant head injury with substantial loss of consciousness
- Psychiatric hospitalization within the past 6 months
- Other MRI contraindications
- Participation in other therapeutic trials
- Active suicidal thoughts
- Documented peripheral neuropathy of known cause (e.g., diabetic neuropathy, chemotherapy-induced neuropathy, Guillain-Barre syndrome)
- Routine or daily use of narcotics or substance abuse
- Autoimmune or inflammatory diseases causing pain (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease)
- History of lower limb vascular surgery or current vascular dysfunction in lower limbs
- Any impairment or situation that would prevent satisfactory completion of the study protocol, including unreliable or inconsistent pain reports as judged by study staff
AI-Screening
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Trial Site Locations
Total: 1 location
1
Athinoula A. Martinos Center for Biomedical Imaging
Boston, Massachusetts, United States, 02129
Actively Recruiting
Research Team
S
Soobin Choi, schoi38@mgb.org
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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