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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from National Institutes of Health Clinical Center (CC)

Record History

The 50 most recent of 160 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv160 Show 6 more changesShow less
    • Phase changed: Phase 2 → not applicable
    • Sponsor changed: National Institute of Neurological Disorders and Stroke (NINDS) to National Institutes of Health Clinical Center (CC)
    • Results first posted: Aug 12, 2026
    • Enrollment increased: 21 → 25 participants
    • Secondary endpoints revised (3)
    • Collaborators expanded, about 8 words
  2. Trial status: Recruiting to Active, Not Recruitingv159 Show 4 more changesShow less
    • Enrollment target: estimated 30 to confirmed 21
    • Primary completion date changed from estimate of Jul 1, 2031 to Apr 25, 2025
    • Study completion date: Jul 1, 2031 to Dec 1, 2026
    • Site details revised
  3. 6 versions Re-verified since Dec 11, 2024, no change to tracked fieldsv153-v158
  4. Study description expanded, about 1 wordv152
  5. Enrollment target: 50 to 30v151
  6. 40 versions Re-verified since May 24, 2022, no change to tracked fieldsv111-v150
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05155059
Lead Sponsor National Institutes of Health Clinical Center (CC)
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Functional Movement Disorder
Related terms Conversion Disorder
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov