NCT07525063

Pain & Reward Neuromodulation of CNS Circuits

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a study to compare activity in the brains of female adults with chronic pain before and after a new intervention. What the researchers learn by doing this study may help them understand how the brain works and how to develop new and targeted treatments for adults with chronic pain. Female participants in this study will come to Duke Hospital for up to 6 visits. First, there is an MRI scan visit. Then, there are 4 intervention (TMS) visits, one after the other over 4 days. Next, there is an identical follow up MRI scan visit. Afterwards, there is a one month, three month, and six month follow up that can be completed remotely. During each of 2 MRI study visits, participants will: * Have a urine test for drug use (and pregnancy if applicable) * Have a blood draw to measure inflammation and/or genetic testing * Have magnetic resonance imaging (MRI) scans of the brain and spine * Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires During each of 4 TMS study visits, participants will: * Have brief transcranial magnetic stimulation (TMS) applied to the head * Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires Participation is complete once the requested study visits and follow-up questionnaires have been completed.

Conditions

• Fibromyalgia Syndrome
• Fibromyalgia
• Chronic Pain and Fatigue

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation (TMS)	TMS protocol delivered via MagPro X100 stimulator with figure-8 coil targeting prefrontal cortex.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated device study