Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial
SPIRE Therapeutics Inc.
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide informed consent. 2. Age ≥ 22 years. 3. Meets 2016 American College of Rheumatology criteria for fibromyalgia: 1. Generalized pain, defined as pain in at least 4 of 5 regions, is present, AND 2. Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9, AND 3. Symptoms have been present at a similar level for at least 3 months, AND 4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically…
Interventions
- DeviceFocused Ultrasound
DIADEM device
Locations (4)
- University of Minnesota Medical Center FairviewMinneapolis, Minnesota
- Northwell Health - The Feinstein Institutes of Clinical ResearchManhasset, New York
- University of UtahSalt Lake City, Utah
- WVU Rockefeller Neuroscience InstituteMorgantown, West Virginia