Recruiting

Ultrasound brain stimulation for fibromyalgia pain relief

Plain-English translation of NCT07226648 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing a noninvasive procedure called focused ultrasound neuromodulation—a treatment that uses sound waves to gently stimulate a specific area of the brain involved in pain processing. Researchers believe this approach may help reduce fibromyalgia pain in people whose symptoms haven't improved with standard medications or therapies. You would receive four ultrasound treatments over one month and complete surveys throughout a 16-week study period.

Many people with fibromyalgia don't get enough relief from existing treatments like antidepressants, anti-seizure medications, or physical therapy. This trial is exploring whether targeting the brain's pain-processing center with ultrasound could offer a new option for those who have tried and failed other approaches.

Do you qualify?

You likely qualify if…

you are at least 22 years old
you have been diagnosed with fibromyalgia based on American College of Rheumatology criteria (widespread pain affecting at least 4 of 5 body regions for at least 3 months)
you have tried at least two standard fibromyalgia medications (such as pregabalin, duloxetine, or milnacipran) without adequate relief
you have tried at least one form of physical therapy, exercise, or behavioral therapy (such as yoga, water exercise, massage, or cognitive behavioral therapy)
you are experiencing fibromyalgia pain rated 4 or higher on a pain scale at both screening and baseline visits
you are willing and able to stay on your current psychiatric medications or therapy (if any) throughout the study

You likely don't qualify if…

you have not tried at least two standard fibromyalgia medications or one physical/behavioral therapy approach
you are pregnant or planning to become pregnant during the study
you have significant neurological, cardiac, or psychiatric conditions that would make brain stimulation unsafe
you have implanted metal devices in your head or brain that would interfere with ultrasound treatment

What participation looks like

You will visit the clinic four times over the course of one month to receive ultrasound treatments—either real focused ultrasound or a sham (placebo) ultrasound. You won't know which treatment you're receiving. Throughout the 16-week study, you'll complete surveys and questionnaires to track your pain levels and symptoms. The entire study lasts 16 weeks, with most of the treatment happening in the first month.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(6 sites)

United States

University of Michigan, Ann Arbor, Michigan

University of Minnesota Medical Center Fairview, Minneapolis, Minnesota

Washington University in St. Louis, St Louis, Missouri

Northwell Health - The Feinstein Institutes of Clinical Research, Manhasset, New York

University of Utah, Salt Lake City, Utah