Personalized Ultrasonic Brain Stimulation for Fibromyalgia

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07361328
Status
Recruiting
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Conditions

  • Fibromyalgia (FM)

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-intensity ultrasound brain stimulation — DEVICE
    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.
  • Sham (No Treatment) — DEVICE
    There will be no ultrasound stimulation delivered

Study Details

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

Key Dates

Start date
Jan 5, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ultrasound Group
    Participants in this group will receive low-intensity ultrasound brain stimulation
  • Sham Comparator: Sham control
    Participants in this group will undergo the same procedure with the Ultrasound group but do not receive ultrasound stimulation

Primary Outcome Measure

Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain) [ Time Frame: 15 days after the first treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pain Research Center, University of UtahSalt Lake CityUtah84108-

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By research site
Pain Research Center, University of Utah· Salt Lake City, UT

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