Personalized Ultrasonic Brain Stimulation for Fibromyalgia
ConditionFibromyalgia (FM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorUniversity of Utah
About this trial
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
Qualifiers
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
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) 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.
Trial design
Treatments tested in this trial
- Low-intensity ultrasound brain stimulation
- Sham (No Treatment)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov