Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
Trial Parameters
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Brief 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 Criteria
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 important illnesses. 4. Failure of at least two evidence-based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia. 5. Failure of one or more attempts at physical or Cognitive Behavioral Therapy (CBT) including: 1. Aerobic exercise like walking, cycling, and swimming, 2. Water therapy/hydrotherapy with warm water exercises, 3. Tai Chi involving slow, controlled movements, 4