๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-18

Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia (NCT07226648)

Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: SPIRE Therapeutics Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Michigan โ€” Ann Arbor, Michigan

Age range: 22 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • University of Michigan โ€” Ann Arbor, Michigan
  • University of Minnesota Medical Center Fairview โ€” Minneapolis, Minnesota
  • Washington University in St. Louis โ€” St Louis, Missouri
  • Northwell Health - The Feinstein Institutes of Clinical Research โ€” Manhasset, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • University of Utah โ€” Salt Lake City, Utah
  • WVU Rockefeller Neuroscience Institute โ€” Morgantown, West Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (801) 585-7690

Email: Akiko.Okifuji@hsc.utah.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Fibromyalgia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—