MRI free targeting of deep brain structures based on facial landmarks.
Thomas S Riis, Seth Lunt, Jan Kubanek
https://pubmed.ncbi.nlm.nih.gov/39755367Actively Recruiting
Phase Not Applicable
Age: 22Years - 70Years
All Genders
ID07361328
Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms
Led by University of Utah · Updated on 2026-01-23
50
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new noninvasive brain stimulation method using an investigational ultrasound device to potentially help people with fibromyalgia. This research involves 50 participants diagnosed with fibromyalgia who have tried and not responded to certain medications and physical therapies. The study aims to compare the effects of active low-intensity ultrasound brain stimulation with a sham procedure that emits no ultrasound. Participants will be randomly assigned to either the treatment group receiving low-intensity ultrasound stimulation or a sham group receiving no ultrasound. The treatment involves wearing a device resembling oversized goggles that deliver ultrasound waves to targeted brain areas. Each participant will attend 6 treatment sessions lasting about 45 minutes each, spread over a two-week period. MRI scans will be done during the first and optionally the last in-person visits. Additionally, participants will complete online assessments multiple times during and after the treatment period. During the study, participants will visit the study center seven times for assessments and treatments, and complete seven online questionnaires about pain and symptoms. These include MRI scans, daily pain ratings, and symptom questionnaires conducted before, during, and up to 60 days after the first treatment session. Researchers will monitor pain levels, fibromyalgia impact, mood, and safety measures throughout. The primary outcome measured is pain intensity 15 days after starting treatment. The study ends after the last online questionnaire session.
CONDITIONS
Brief Title
Personalized Ultrasonic Brain Stimulation for Fibromyalgia
Who Can Participate
Age: 22Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Meet American College of Rheumatology criteria for fibromyalgia, including widespread pain in at least 4 of 5 regions
- Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) score ≥ 5, or WPI 4-6 and SSS score ≥ 9
- Symptoms present at a similar level for at least 3 months
- Diagnosis of fibromyalgia is valid even if other illnesses are present
- Failed treatment with at least two medications like pregabalin, duloxetine, or milnacipran
- Failed one or more attempts at physical therapy or related therapies such as aerobic exercise, water therapy, Tai Chi, yoga, resistance training, massage, and others
- Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at screening and baseline visits
- Willingness and ability to comply with study procedures and remain on the same psychiatric treatment regimen for at least 1 month before screening and during the study
- For reproductive potential participants: negative pregnancy test at screening and agreement to use highly effective contraception
- Able and willing to provide informed consent
You will not qualify if you...
- Any lifetime diagnosis of bipolar disorder or schizophrenia-spectrum disorder
- Moderate or severe alcohol or substance use disorder in the past 6 months
- Obsessive compulsive disorder or posttraumatic stress disorder in the past 30 days if unstable
- Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months
- Clinically significant neurodevelopmental, neurocognitive, or personality disorder
- Moderate to high risk of suicide based on Columbia-Suicide Severity Rating Scale or clinical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Daily Pain Rating
Duration - 2 days
Participants record their average and worst pain once a day for two consecutive days before starting treatment.
2 virtual pain rating sessions
MRI and 1st Treatment Session
Duration - 1 day
Participants undergo an MRI scan followed by the first ultrasound brain stimulation treatment session or sham session, including questionnaires.
1 in-person visit
Treatment
Duration - 2 weeks
Participants receive a total of 6 ultrasound brain stimulation or sham sessions over 2 weeks with at least 24 hours between sessions. Questionnaires and side effect reports are collected during these visits.
6 in-person treatment sessions
MRI and Last Treatment Session
Duration - 1 day
Participants receive the last treatment session and may undergo an optional second MRI scan. Questionnaires are completed as part of this visit.
1 in-person visit
Follow-up
Duration - 45 days
Participants complete online symptom questionnaires at several time points after the first treatment session to monitor pain and impact of fibromyalgia.
5 virtual questionnaire sessions at 15, 22, 29, 45, and 60 days after first treatment
Trial Site Locations
Total: 1 location
1
Pain Research Center, University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
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Research Team
M
Madison Bunnell, Research Study coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Noninvasive targeted modulation of pain circuits with focused ultrasonic waves.
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https://pubmed.ncbi.nlm.nih.gov/39073370