RecruitingNot Applicable

Personalized Ultrasonic Brain Stimulation for Fibromyalgia

United States50 participantsStarted 2026-01-05

Plain-language 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

Who can participate

Age range

22 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 trigger points, * Massage therapy, * Trigger point therapy targeting specific pain points, * Joint mobilization, * Postural retraining to correct body alignment, * Balance and coordination exercises, * Feldenkrais method for movement awareness, * Alexander technique to enhance posture and movement efficiency, * Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, * Heat therapy using hot packs, infrared, or paraffin wax, * Cold therapy …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)

Timeframe: 15 days after the first treatment

Trial details

NCT IDNCT07361328

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Madison Bunnell, Research Study coordinator

385-209-1070 madison.bunnell@utah.edu

View on ClinicalTrials.gov More Fibromyalgia (FM) trials