Clinical Trial

Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

Active, Not Recruiting
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Summary
Background: Functional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD. Objective: To test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms. Eligibility: People between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist. Design: Participants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group. Participants will have a baseline visit. This will include: Neurological exam Questionnaires Urine test Brain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner. Within 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles. Participants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.
Protocol Amendment History 4 changes
critical Phase changed: Phase 2 -> not applicable 2026-08-13
critical Primary endpoint(s) modified 2026-08-13
notable Enrollment increased: 21 -> 25 participants 2026-08-13
notable Sponsor changed: National Institute of Neurological Disorders and Stroke (NINDS) -> National Institutes of Health Clinical Center (CC) 2026-08-13
Trial Details
NCT Number NCT05155059
Lead Sponsor National Institutes of Health Clinical Center (CC)
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Functional Movement Disorder
Enrollment 25 participants
Start Date 2022-05-06
Primary Completion 2025-04-25 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-12