Ultrasonic Neuromodulation for Fibromyalgia Pain

This study is looking into a new way to help people with fibromyalgia (widespread body pain and tenderness). It's testing a device called DIADEM, which uses focused ultrasound (sound waves) to stimulate a specific part of the brain called the cingulate cortex. The main goal is to see if this treatment can reduce your pain. You might be able to join if you are at least 22 years old and meet the criteria for fibromyalgia. The study will measure pain using a scale called NRS-11 (Numerical Rating Scale - 11) 28 days after your first treatment. The current status of this study is unclear, and it plans to enroll 180 participants.

Study design
This interventional study plans to enroll 180 participants. It is testing a device called DIADEM.
What's involved
You would receive four treatments over one month and complete surveys at different times throughout the 16-week study.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured 28 days after your initial treatment, and you will complete surveys throughout the 16-week study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226648

Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

Recruiting
NAAges 22+InterventionalTreatment
SPIRE Therapeutics Inc.
~180 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Focused Ultrasound

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical Rating Scale - 11 (NRS-11) pain score
Measured over 28 days following initial treatment
Fibromyalgia
8 sites across 7 states
New York2
Michigan1
Minnesota1
Missouri1
Pennsylvania1
Utah1
West Virginia1
  • Akiko Okifuji, PhD · PRINCIPAL_INVESTIGATOR · University of Utah

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  • Numerical Rating Scale - 11 (NRS-11) pain score28 days following initial treatment

    The NRS-11 is a scale from 0-10 with higher values representing higher levels of pain.