Actively Recruiting
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
Led by SPIRE Therapeutics Inc. · Updated on 2026-04-16
180
Participants Needed
4
Research Sites
50 weeks
Total Duration
On this page
Sponsors
S
SPIRE Therapeutics Inc.
Lead Sponsor
U
University of Utah Data Coordinating Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study.
CONDITIONS
Official Title
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent.
- Age 22 years or older.
- Meets 2016 American College of Rheumatology criteria for fibromyalgia including generalized pain in at least 4 of 5 regions, specific symptom severity scores, and symptoms present for at least 3 months.
- Diagnosis of fibromyalgia is valid even with other illnesses present.
- Failure of at least two evidence-based fibromyalgia medications such as pregabalin, duloxetine, or milnacipran.
- Failure of one or more physical or cognitive behavioral therapies including aerobic exercise, water therapy, Tai Chi, yoga, resistance training, bodyweight exercises, Pilates, myofascial release, massage, trigger point therapy, joint mobilization, postural retraining, balance exercises, Feldenkrais method, Alexander technique, TENS, heat or cold therapy, ultrasound therapy, biofeedback, stretching, proprioceptive neuromuscular facilitation, hydrotherapy pool exercises, Ai Chi, underwater treadmill therapy, graded motor imagery, mirror therapy, mindfulness-based stress reduction, gaze stabilization, or CBT.
- Pain score of 4 or higher on the Numerical Rating Scale (NRS-11) at screening and baseline visits.
- Willingness and ability to comply with all study procedures.
- Stable psychiatric treatment for at least one month prior to screening and willingness to maintain this during the study.
- Negative pregnancy test if able to become pregnant and agreement to use highly effective contraception.
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 disorders.
- Moderate to high suicide risk or history of serious suicide attempt.
- Changes in pain treatment in the past 2 months.
- Recent treatment with electroconvulsive therapy, transcranial magnetic stimulation, ketamine, or esketamine.
- Progressive neurological diseases like multiple sclerosis or brain/spinal cord tumors.
- Cancer-related pain or malignancy with life expectancy under one year.
- Autoimmune-related pain or inadequately managed medical conditions.
- History of cerebral small vessel disease or intracranial hemorrhage.
- Pregnancy or breastfeeding.
- Implanted medical device in the head or neck.
- MRI contraindication or intolerance.
- Previous participation in a DIADEM clinical trial except one screen failure rescreen.
- Medical or psychiatric conditions that may reduce ability to participate, affect data integrity, or increase risk.
- Hairstyles preventing access to the side of the head who are unwilling to adjust them temporarily.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
Northwell Health - The Feinstein Institutes of Clinical Research
Manhasset, New York, United States, 10030
Actively Recruiting
3
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
4
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
A
Akiko Okifuji, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here