Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms
University of Utah
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
Description
In this study, investigators will recruit 50 people with fibromyalgia. Participants will be asked to go through each of the following steps: 1\. (In Person or Virtual) Initial visit (screening, medical history, questionnaires, 1 hour) 2. (Virtual) 2 daily pain ratings over two consecutive days (10 min each) 3. (In Person) MRI and 1st treatment session (MRI 1 hour, treatment 45 min, questionnaires 30 min) 4. (In Person) 4 treatment session visits (treatment 45 min each, questionnaires 30 min each) 5. (In Person) MRI (Optional) and last treatment session (MRI 1 hour, treatment 45 min, questionn…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- DeviceLow-intensity ultrasound brain stimulation
The device is called BEAM, which looks like an oversized pair of goggles that can be fitted over a participant's head. Once fastened, it emits a low-intensity ultrasound wave from your temples that targets a specific area of the brain. The treatment lasts about 45 minutes per session. In this study, participants will undergo a total of 6 sessions within a period of 2 weeks.
- DeviceSham (No Treatment)
There will be no ultrasound stimulation delivered
Location
- Pain Research Center, University of UtahSalt Lake City, Utah