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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Low-intensity ultrasound brain stimulation
Device
The device is called BEAM, which looks like an oversized pair of goggles that can be fitted over a participant's head. Once fastened, it emits a low-intensity ultrasound wave from your temples that targets a specific area of the brain. The treatment lasts about 45 minutes per session. In this study, participants will undergo a total of 6 sessions within a period of 2 weeks.
Sham (No Treatment)
Device
There will be no ultrasound stimulation delivered

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Ultrasound GroupExperimental treatment 1 intervention

Group B: Sham controlSham comparator 1 intervention

Trial outcomes

Primary outcomes

Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)

Pain score on the 0-10 scale at Day 15 following the first treatment

Time frame

15 days after the first treatment

Secondary outcomes

Fibromyalgia Impact Questionnaire Revised +15days. 0 (no impact) - 100 (severe impact)

Day15 Fibromyalgia Impact Questionnaire- Revised

Time frame

15 days after the first treatment

Day15 PROMIS29 (Patient-Reported Outcomes Measurement Information System) Interference scale: (20 little/no interference) - 80 (very high interference)

PROMIS-29 (Patient-Reported Outcomes Measurement Information System - Pain interference subscale)

Time frame

15 days after the first treatment

Response Rate 30%

At least 30% reduction in numerical pain score at Day 7

Time frame

7 days after the first treatment

Patient Global Impression of Improvement (1 Very much better - 7 very much worse)

Patient's own assessment of how much symptoms are improved at Day 15

Time frame

15 days after the first treatment

Other outcomes

Day 15 Patient-Reported Outcomes Measurement Information System) other scales: (20 little/no problem ) - 80 (very high level of problem)

Scores of PROMIS 20 scales other than interference at Day 15

Time frame

15 days after the first treatment

Day 15 Brief Pain Inventory - short form (BPI-S) 0 no pain - 10 pain as bad as you can imagine

Scores of BPI-S pain scales at Day 15

Time frame

15 days after the first treatment

Day 60 Fibromyalgia Impact Questionnaire Revised. 0 (no impact) - 100 (severe impact)

Fibromyalgia Impact Questionnaire Revised scores at Day 60

Time frame

60 days after the first treatment

Day 60 Brief Pain Inventory: 0 (no problem) - 10 (worst problem)

Brief Pain Inventory scores at Day 60

Time frame

60 days after the first treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov

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