Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
SPIRE Therapeutics Inc.
Study ID
NCT07226648
Status
Recruiting
Apply to this trial

Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focused Ultrasound — DEVICE
    DIADEM device

Study Details

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.

Key Dates

Start date
Dec 11, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Focused Ultrasound
  • Sham Comparator: Sham Ultrasound

Primary Outcome Measure

Numerical Rating Scale - 11 (NRS-11) pain score [ Time Frame: 28 days following initial treatment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Katherine Scott, RN, BSN
[email protected]
734-998-7022
Daniel Clauw, MD (PRINCIPAL_INVESTIGATOR)
Deeba Minhas, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota Medical Center FairviewMinneapolisMinnesota55455
Eric Williamson
[email protected]
612-626-6183
Alik Widge, MD, PhD (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Cristina Bowman, RN
[email protected]
314-273-8257
Simon Haroutounian, PhD, MSc.Pharm (PRINCIPAL_INVESTIGATOR)
Northwell Health - The Feinstein Institutes of Clinical ResearchManhassetNew York10030
Clinical Research Team
[email protected]
516-253-7753
Ashesh Mehta, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Rachel Douglas, BS, CCRC
[email protected]
801-587-2811
Rana Jawish, MD (PRINCIPAL_INVESTIGATOR)
WVU Rockefeller Neuroscience InstituteMorgantownWest Virginia26505
Tami Deal, CCRC
[email protected]
304-293-0930
Manish Ranjan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MIUniversity of Minnesota Medical Center Fairview· Minneapolis, MNWashington University in St. Louis· St Louis, MONorthwell Health - The Feinstein Institutes of Clinical Research· Manhasset, NYUniversity of Utah· Salt Lake City, UTWVU Rockefeller Neuroscience Institute· Morgantown, WV

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