NCT07361328 Personalized Ultrasonic Brain Stimulation for Fibromyalgia

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 50 participants in total. It began in 2026-01-05 with a primary completion date of 2028-12-31.

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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, * Ultrasound therapy for deep tissue relaxation, * Biofeedback to control muscle tension and pain response, * Gentle static stretching for prolonged duration, * Active dynamic stretching for full range of motion, * Proprioceptive Neuromuscular Facilitation (PNF) stretching, * Hydrotherapy pool exercises, * Ai Chi (water-based Tai Chi), * Underwater treadmill therapy, * Graded motor imagery (GMI), * Mirror therapy to retrain brain-body connections, * Mindfulness-based stress reduction (MBSR) combining meditation and movement, * Cognitive-behavioral therapy * Gaze stabilization techniques for dizziness and disorientation * Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit. * Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Baseline visit. * Stated willingness and ability to comply with all study procedures, to receive no additional interventions, and to remain on the same psychiatric treatment regimen (e.g., medication, psychotherapy) beginning at least one (1) month prior to screening and for the duration of the main study period unless a change in treatment is recommended or agreed upon by the site principal investigator. * For participants of reproductive potential: negative urine or blood pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC). * Willing and able to provide informed consent Exclusion Criteria: * 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).

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