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Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

NCT07226648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Focused Ultrasound

DIADEM device

Sponsors & Collaborators

  • University of Utah Data Coordinating Center

    collaborator UNKNOWN

  • SPIRE Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Akiko Okifuji, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226648 on ClinicalTrials.gov