Low-Intensity Ultrasound Brain Stimulation to Treat Fibromyalgia Symptoms A Randomized Study Comparing Active and Sham Treatments

What this Trial Is About

Researchers are evaluating a new noninvasive brain stimulation method using an investigational ultrasound device to potentially help people with fibromyalgia. This research involves 50 participants diagnosed with fibromyalgia who have tried and not responded to certain medications and physical therapies. The study aims to compare the effects of active low-intensity ultrasound brain stimulation with a sham procedure that emits no ultrasound. Participants will be randomly assigned to either the treatment group receiving low-intensity ultrasound stimulation or a sham group receiving no ultrasound. The treatment involves wearing a device resembling oversized goggles that deliver ultrasound waves to targeted brain areas. Each participant will attend 6 treatment sessions lasting about 45 minutes each, spread over a two-week period. MRI scans will be done during the first and optionally the last in-person visits. Additionally, participants will complete online assessments multiple times during and after the treatment period. During the study, participants will visit the study center seven times for assessments and treatments, and complete seven online questionnaires about pain and symptoms. These include MRI scans, daily pain ratings, and symptom questionnaires conducted before, during, and up to 60 days after the first treatment session. Researchers will monitor pain levels, fibromyalgia impact, mood, and safety measures throughout. The primary outcome measured is pain intensity 15 days after starting treatment. The study ends after the last online questionnaire session.

Personalized Ultrasonic Brain Stimulation for Fibromyalgia