Personalized Ultrasonic Brain Stimulation for Fibromyalgia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia (FM)

In brief

The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, which might be useful for treating fibromyalgia. The device is for investigational use only and is not yet approved by the FDA for the intended use. * Participants will be asked to visit the study center 7 times for in-person assessment and treatment sessions. In addition, participants will be asked to complete an online assessment 7 times. During in-person or online visits: * Participants will undergo an MRI scan twice during the first and last in-person visit (1 hour each) The second MRI may be optional. * There will be 6 treatment sessions (45 minutes each) within a 2-week period * The online assessment occurs (15 minutes each) * two consecutive days before the first treatment session * 15 days after the first treatment session * 22 days after the first treatment session * 29 days after the first treatment session * 44 days after the first treatment session * 60 days after the first treatment session

Key facts

Study ID

NCT07361328

Run by

University of Utah

People needed

50

Starts

2026-01-05

Expected to finish

2028-12-31

Last updated by the study team

2026-01-23

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets American College of Rheumatology criteria for fibromyalgia:
• Generalized pain, defined as pain in at least 4 of 5 regions, is present.
• Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9.
• Symptoms have been present at a similar level for at least 3 months.
• d.A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses
• Failure of at least two evidence based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.
• Failure of one or more attempts at physical therapy including:
• Aerobic exercise like walking, cycling, and swimming,
• Water therapy/hydrotherapy with warm water exercises,
• Tai Chi involving slow, controlled movements,
• Yoga,
• Resistance training,
• Bodyweight exercises,
• Pilates,
• Myofascial release therapy applying gentle pressure on trigger points,
• Massage therapy,
• Trigger point therapy targeting specific pain points,
• Joint mobilization,
• Postural retraining to correct body alignment,
• Balance and coordination exercises,
• Feldenkrais method for movement awareness,
• Alexander technique to enhance posture and movement efficiency,
• Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,
• Heat therapy using hot packs, infrared, or paraffin wax,
• Cold therapy with ice packs or cryotherapy,

You may not qualify if…

• 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) criteria.
• Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.
• Diagnosis of obsessive compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is unstable in the clinical judgment of the investigator.
• Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.
• Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 criteria.
• Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site principal investigator (PI).

Where it is running

• Pain Research Center, University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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