On November 12, 2025, a groundbreaking clinical trial was highlighted as ‘not yet recruiting’ on ClinicalTrials.gov. The study, sponsored by SPIRE Therapeutics Inc. and the University of Utah Data Coordinating Center, aims to explore a novel approach to fibromyalgia management. Utilizing focused ultrasound technology, the trial seeks to evaluate the effects of non-invasive neuromodulation on the cingulate cortex. Fibromyalgia patients and stakeholders in medical device development should monitor this promising development.
In this article:
- What is the purpose of the trial?
- Why targeted ultrasound for fibromyalgia?
- How will the trial be conducted?
- FAQ
- Conclusion
- Disclaimer
- Announcement & Link
What is the purpose of the trial?
The trial, titled “Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial,” investigates whether focused ultrasound can reduce fibromyalgia symptoms by modulating brain activity. SPIRE Therapeutics Inc., the manufacturer involved, describes the device as a non-invasive technology intended to target specific neurocircuitry. This aligns with trends in precision medicine aiming to personalize interventions while minimizing invasiveness.
Why targeted ultrasound for fibromyalgia?
Fibromyalgia affects millions worldwide, causing widespread pain and fatigue. Conventional treatments include pharmaceuticals and physical therapy, yet many patients report incomplete relief. Neuromodulation, particularly focused ultrasound, introduces a new frontier by influencing neural activity within pain-processing regions like the cingulate cortex. This methodology has shown promise in other neurological conditions, setting high expectations for fibromyalgia research.
How will the trial be conducted?
Overview of design
The trial design includes randomized selection, blinding, and a sham-controlled format to ensure scientific rigor. Patients in the study will either receive active treatment or serve as part of the sham-controlled comparator arm. Outcomes will measure reductions in reported pain, changes in neural markers, and overall device safety and performance.
Regulatory framework
ClinicalTrials.gov lists the trial as “not yet recruiting,” signaling compliance with pre-trial regulatory protocols. FDA clearance of trial phases for medical devices dictates strict adherence to safety and efficacy reviews. Based on study outcomes, commercialization could follow, impacting practices in neuromodulation.
FAQ
- Who can participate? As the study is not yet recruiting, inclusion criteria for fibromyalgia patients will be published upon activation.
- What is the primary device? Focused ultrasound technology aimed at neuromodulation.
- What are the safety considerations? The device originates from manufacturers with structured compliance to regulatory measures, focusing on non-invasive mechanisms to limit risks.
- How will findings be presented? Trial results will undergo peer review and publication after completion.
Conclusion
The initiation of this clinical trial signifies the evolution of fibromyalgia treatment options. Stakeholders, including clinical teams, device manufacturers, and regulators, should stay informed as advancements unfold in 2025. Careful monitoring will offer insight into pain management breakthroughs.
Disclaimer
This article provides general information on upcoming research developments and should not be interpreted as legal, clinical, or regulatory advice. Consult regulatory guidelines directly for detailed compliance requirements.
Announcement & Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07226648?term=medical+device