Not Yet RecruitingNot Applicable

Pain & Reward Neuromodulation of CNS Circuits

30 participantsStarted 2026-05

Plain-language summary

This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female and ages 18 +
✓. Ability to read/understand English and give consent to participate
✓. Physician diagnosis \& confirmation of primary fibromyalgia syndrome

Exclusion criteria

✕. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study
✕. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)
✕. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)
✕. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)
✕. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)
✕. male \*
✕. current hypomania,
✕. meets diagnostic criteria for current psychotic disorder, or psychotic features,

What they're measuring

Change in Pain Intensity

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)

Change in Fatigue

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)

Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)

Trial details

NCT IDNCT07525063

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Martucci Lab Clinical Research Specialist

919-684-3161 ChronicPainResearch@duke.edu

View on ClinicalTrials.gov More Fibromyalgia Syndrome trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female and ages 18 +
✓. Ability to read/understand English and give consent to participate
✓. Physician diagnosis \& confirmation of primary fibromyalgia syndrome

Exclusion criteria

✕. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study
✕. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)
✕. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)
✕. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)
✕. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)
✕. male \*
✕. current hypomania,
✕. meets diagnostic criteria for current psychotic disorder, or psychotic features,

What they're measuring

Change in Pain Intensity

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)

Change in Fatigue

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)

Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)

Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)