Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSPIRE Therapeutics Inc.
About this trial
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 criteria
Qualifiers
Willing and able to provide informed consent.
Age ≥ 22 years.
Generalized pain, defined as pain in at least 4 of 5 regions, is present, AND
Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9, AND
Disqualifiers
Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5-TR) criteria.
New or existing diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5-TR criteria.
New or existing diagnosis of obsessive-compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5-TR criteria, and which is unstable in the clinical judgment of the investigator.
New or existing primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5-TR criteria.
Trial design
Treatments tested in this trial
- Focused Ultrasound
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
6Michigan
University of Michigan48109, Ann Arbor United States
Minnesota
University of Minnesota Medical Center Fairview55455, Minneapolis United States
Missouri
Washington University in St. Louis63110, St Louis United States
New York
Northwell Health - The Feinstein Institutes of Clinical Research10030, Manhasset United States
Sponsors and collaborators
SPIRE Therapeutics Inc.
Lead sponsor
University of Utah Data Coordinating Center
Collaborator
Source ClinicalTrials.gov