Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Trial Parameters
Brief Summary
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 treatment sessions. In addition, participants will be asked to complete an online assessment 7 times. During in-person or online visits: * Participants will undergo an MRI scan twice during the first and last in-person visit (1 hour each) The second MRI may be optional. * There will be 6 treatment sessions (45 minutes each) within a 2-week period * The online assessment occurs (15 minutes each) * two consecutive days before the first treatment session * 15 days after the first treatment session * 22 days after the first treatment session * 29 days after the first treatment session * 44 days after the first treatment session * 60 days after the first treatment session
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 been present at a similar level for at least 3 months. * d.A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses * Failure of at least two evidence based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia. * Failure of one or more attempts at physical therapy including: * Aerobic exercise like walking, cycling, and swimming, * Water therapy/hydrotherapy with warm water exercises, * Tai Chi involving slow, controlled movements, * Yoga, * Resistance training, * Bodyweight exercises, * Pilates, * Myofascial release therapy applying gentle pressure on tr