Trials / Recruiting
RecruitingNCT07226648
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- SPIRE Therapeutics Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Focused Ultrasound | DIADEM device |
Timeline
- Start date
- 2025-12-11
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-11-10
- Last updated
- 2026-04-16
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07226648. Inclusion in this directory is not an endorsement.