Personalized Ultrasonic Brain Stimulation for Fibromyalgia
This study is exploring a new way to treat fibromyalgia using a device called BEAM. This device looks like goggles and uses low-intensity ultrasound waves to target a specific area of your brain. The goal is to see if this personalized brain stimulation can help reduce your pain. You might be able to join if you are between 22 and 70 years old and meet the American College of Rheumatology criteria for fibromyalgia, which includes experiencing widespread pain for at least 3 months. The study aims to enroll 50 participants and will measure your pain levels 15 days after your first treatment to see if the intervention is successful. This device is still being investigated and is not yet approved by the FDA.
- Study design
- This is an interventional study with 50 participants. Some participants will receive the ultrasound stimulation, while others will receive a sham (no treatment) device.
- What's involved
- You will visit the study center 7 times for assessments and treatment sessions, and complete 7 online assessments. This includes two MRI scans (one optional) and several treatment sessions, each lasting about 45 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will complete online questionnaires for about 60 days after your first treatment session to track your progress.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07361328
Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Recruiting
NAAges 22–70InterventionalTreatmentUniversity of UtahInvestigator-initiated
~50 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Low-intensity ultrasound brain stimulationSham (No Treatment)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)
Measured over 15 days after the first treatment
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Akiko Okifuji, PhD · PRINCIPAL_INVESTIGATOR · University of Utah
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 with ice packs or cryotherapy,
Ultrasound therapy for deep tissue relaxation,
Biofeedback to control muscle tension and pain response,
Gentle static stretching for prolonged duration,
Active dynamic stretching for full range of motion,
Proprioceptive Neuromuscular Facilitation (PNF) stretching,
Hydrotherapy pool exercises,
Ai Chi (water-based Tai Chi),
Underwater treadmill therapy,
Graded motor imagery (GMI),
Mirror therapy to retrain brain-body connections,
Mindfulness-based stress reduction (MBSR) combining meditation and movement,
Cognitive-behavioral therapy
Gaze stabilization techniques for dizziness and disorientation
Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.
Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Baseline visit.
Stated willingness and ability to comply with all study procedures, to receive no additional interventions, and to remain on the same psychiatric treatment regimen (e.g., medication, psychotherapy) beginning at least one (1) month prior to screening and for the duration of the main study period unless a change in treatment is recommended or agreed upon by the site principal investigator.
For participants of reproductive potential: negative urine or blood pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC).
Willing and able to provide informed consent
Exclusion
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).
What this trial measures
- Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)15 days after the first treatment
Pain score on the 0-10 scale at Day 15 following the first treatment