RecruitingNot ApplicableNCT07226648

Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

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

Sponsor

SPIRE Therapeutics Inc.

Enrollment

180 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Fibromyalgia

Summary

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Focused Ultrasound for people with fibromyalgia. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFocused Ultrasound

DIADEM device

Locations(8)

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

Northwell Health - The Feinstein Institutes of Clinical Research

Manhasset, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07226648

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