Personalized ultrasonic brain stimulation to reduce fibromyalgia symptoms

Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms

This study will test whether personalized low-intensity ultrasound to the brain can reduce pain and other symptoms in adults with fibromyalgia who have not improved after standard medications and physical therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: University of Utah (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07361328 on ClinicalTrials.gov

What this trial studies

This interventional protocol will enroll 50 adults with fibromyalgia who meet American College of Rheumatology criteria and have failed multiple medications and physical therapy. Participants will be randomized to receive personalized low-intensity ultrasound brain stimulation or a sham control across six treatment sessions delivered over two weeks, with MRI scans at the first and final in-person visits. The schedule includes seven in-person visits (treatments and MRIs) and multiple online questionnaire assessments up to 60 days after the first treatment. Primary outcomes are changes in pain and symptom severity compared with sham stimulation.

Who should consider this trial

Good fit: Ideal candidates are adults with fibromyalgia who meet ACR criteria and have not responded adequately to at least two guideline-recommended medications and at least one course of physical therapy.

Not a fit: People who already have good symptom control with current treatments, cannot undergo MRI, are pregnant, or cannot attend multiple in-person visits in Salt Lake City are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could offer a noninvasive, drug-free option to reduce pain and improve daily function for some people with fibromyalgia.

How similar studies have performed: Ultrasound brain stimulation is an emerging neuromodulation technique with limited early pilot data for pain and neuropsychiatric disorders, so its application specifically for fibromyalgia is largely novel and unproven.

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).

Where this trial is running

Salt Lake City, Utah

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

Study contacts

• Principal investigator: Akiko Okifuji, PhD — University of Utah
• Study coordinator: Madison Bunnell, Research Study coordinator

Conditions Fibromyalgia; Ultrasound brain stimulation; Clinical trials; MRI