Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Recruiting
N/A
Interventional Study
Fibromyalgia (FM)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- University of Utah · Other
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About This Trial
The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, which might be useful for treating fibromyalgia. The device is for investigational use only and is not yet approved by the FDA for the intended use.
* Participants will be asked to visit the study center 7 times for in-person assessment and trea…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Meets American College of Rheumatology criteria for fibromyalgia:
* Generalized pain, defined as pain in at least 4 of 5 regions, is present.
* Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9.
* Symptoms have b…
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