Personalized Ultrasonic Brain Stimulation for Fibromyalgia
BEAMforFMS
Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms
1 other identifier
interventional
50
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2026
CompletedFirst Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 23, 2026
January 1, 2026
3 years
January 6, 2026
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)
Pain score on the 0-10 scale at Day 15 following the first treatment
15 days after the first treatment
Secondary Outcomes (6)
Fibromyalgia Impact Questionnaire Revised +15days. 0 (no impact) - 100 (severe impact)
15 days after the first treatment
Day15 PROMIS29 (Patient-Reported Outcomes Measurement Information System) Interference scale: (20 little/no interference) - 80 (very high interference)
15 days after the first treatment
Response Rate 30%
7 days after the first treatment
Patient Global Impression of Improvement (1 Very much better - 7 very much worse)
15 days after the first treatment
Numerical Rating Scale11 pain score Day 60 (0 No pain - 10 Worst pain)
60 days after the first treatment
- +1 more secondary outcomes
Other Outcomes (6)
Day 15 Patient-Reported Outcomes Measurement Information System) other scales: (20 little/no problem ) - 80 (very high level of problem)
15 days after the first treatment
Day 15 Brief Pain Inventory - short form (BPI-S) 0 no pain - 10 pain as bad as you can imagine
15 days after the first treatment
Day 60 Fibromyalgia Impact Questionnaire Revised. 0 (no impact) - 100 (severe impact)
60 days after the first treatment
- +3 more other outcomes
Study Arms (2)
Ultrasound Group
EXPERIMENTALParticipants in this group will receive low-intensity ultrasound brain stimulation
Sham control
SHAM COMPARATORParticipants in this group will undergo the same procedure with the Ultrasound group but do not receive ultrasound stimulation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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,
- +28 more criteria
You may not qualify if:
- Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria.
- Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.
- Diagnosis of obsessive compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is unstable in the clinical judgment of the investigator.
- Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.
- Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 criteria.
- Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site principal investigator (PI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Research Center, University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (2)
Riis TS, Lunt S, Kubanek J. MRI free targeting of deep brain structures based on facial landmarks. Brain Stimul. 2025 Jan-Feb;18(1):131-137. doi: 10.1016/j.brs.2024.12.1478. Epub 2025 Jan 3.
PMID: 39755367RESULTRiis TS, Feldman DA, Losser AJ, Okifuji A, Kubanek J. Noninvasive targeted modulation of pain circuits with focused ultrasonic waves. Pain. 2024 Dec 1;165(12):2829-2839. doi: 10.1097/j.pain.0000000000003322. Epub 2024 Jul 30.
PMID: 39073370RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akiko Okifuji, PhD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 6, 2026
First Posted
January 23, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share