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Personalized Ultrasonic Brain Stimulation for Fibromyalgia

NCT07361328 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-23

No results posted yet for this study

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

Conditions

  • Fibromyalgia (FM)

Interventions

DEVICE

Low-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.

DEVICE

Sham (No Treatment)

There will be no ultrasound stimulation delivered

Sponsors & Collaborators

Principal Investigators

  • Akiko Okifuji, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07361328 on ClinicalTrials.gov