๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-13

A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM (NCT06167655)

A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: ShiraTronics

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

Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona โ€” Scottsdale, Arizona

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 (23 Sites)

  • Mayo Clinic Arizona โ€” Scottsdale, Arizona
  • University of Arkansas for Medical Sciences โ€” Little Rock, Arkansas
  • UC San Diego Health โ€” La Jolla, California
  • Neurovations โ€” Napa, California
  • Barolat Neuroscience โ€” Denver, Colorado
  • Ayer Neuroscience Institute Headache Center โ€” Hartford, Connecticut
  • Mayo Clinic Florida โ€” Jacksonville, Florida
  • Vista Clinical Research and Summit Spine & Joint โ€” Newnan, Georgia
  • Synergy Headache Center & University of Illiniois Chicago โ€” Chicago, Illinois
  • iSpine Clinics โ€” Chaska, Minnesota
  • University of Minnesota โ€” Minneapolis, Minnesota
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Dent Neurologic Institute โ€” Amherst, New York
  • Northwell Health Physician Partners โ€” New York, New York
  • Montefiore Health โ€” New York, New York
  • Queen City Clinical Research โ€” Charlotte, North Carolina
  • The Center for Clinical Research โ€” Winston-Salem, North Carolina
  • Argires Marotti Neurological Associates โ€” Lancaster, Pennsylvania
  • Jefferson Headache Center โ€” Philadelphia, Pennsylvania
  • Texas Neurology โ€” Dallas, Texas
  • Genesis Research Services โ€” Broadmeadow, New South Wales
  • CerCare โ€” Wayville, South Australia
  • Monash House Research Centre โ€” Melbourne, Victoria

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

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.

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†—