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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with fibromyalgia, a condition that causes chronic pain. The study is testing whether patients can learn to control their own brain activity using special brain scans called real-time fMRI (functional magnetic resonance imaging). By watching their brain activity on a screen, participants will try mental techniques to reduce their pain. Along with the brain scans, participants will also attend weekly sessions with a pain psychologist, where they will either receive Cognitive Behavioral Therapy (CBT), a type of talk therapy, or education about fibromyalgia.

People who might be eligible for this study are adults aged 18 to 65 who have had fibromyalgia for at least a year and experience moderate to severe pain most days. Participants need to be on stable medication and able to speak and understand English. The study involves two visits for brain scans and eight weekly therapy or education sessions. It’s important to know that certain health conditions, medications, or recent mental health issues may exclude someone from joining. This study is not yet recruiting, but it could offer a new way to manage fibromyalgia pain by helping patients actively change how their brain works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-65
• • 2. Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
• • 3. On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
• • 4. Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
• • 5. Able to provide written consent and fluent in English
• Exclusion Criteria:
• • 1. Comorbid acute pain condition
• • 2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
• • 3. Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
• • 4. Pregnant or nursing
• • 5. Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
• • 6. History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
• • 7. Contraindication to MRI (e.g., implanted ferrous metal)
• • 8. History of significant head injury (e.g., with substantial loss of consciousness)
• • 9. Psychiatric hospitalization in the past 6 months
• • 10. Other contraindications to MRI
• • 11. Participating in other therapeutic trials
• • 12. Active suicidal ideation
• • 13. Documented peripheral neuropathy of known cause (e.g diabetic neuropathy, chemotherapy-induced neuropathy, guillain-barre)
• • 14. Routine or daily use of narcotics or substances of abuse
• • 15. Autoimmune or inflammatory disease (RA, SLE, IBD) that causes pain
• • 16. Lower Limb Vascular Surgery or Current Lower Limb Vascular Dysfunction
• • 17. 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.