Actively Recruiting
Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Led by University of Utah · Updated on 2026-01-23
50
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet American College of Rheumatology criteria for fibromyalgia, including generalized pain in at least 4 of 5 regions
- Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9
- Symptoms present at a similar level for at least 3 months
- Diagnosis of fibromyalgia valid even if other illnesses present
- Failure of at least two medications approved for fibromyalgia treatment (e.g., pregabalin, duloxetine, milnacipran)
- Failure of one or more physical therapy methods such as aerobic exercise, water therapy, Tai Chi, yoga, resistance training, massage therapy, and others listed
- Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at screening and baseline visits
- Willingness and ability to comply with study procedures and remain on the same psychiatric treatment regimen for at least one month before screening and during the study unless changes are approved
- Negative pregnancy test for participants of reproductive potential and agreement to use highly effective contraception
- Willing and able to provide informed consent
You will not qualify if you...
- Previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder
- Moderate or severe alcohol or substance use disorder in the past 6 months
- Obsessive compulsive disorder or posttraumatic stress disorder in the past 30 days if unstable
- Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months
- Clinically significant neurodevelopmental, neurocognitive, or personality disorder
- Moderate to high risk of suicide as determined by screening or investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pain Research Center, University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
Research Team
M
Madison Bunnell, Research Study coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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