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NCT05155059 · ClinicalTrials.gov registry record · Phase 2
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
A Phase 2 study of Functional Movement Disorder, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05155059: Active Phase 2 study of Functional Movement Disorder, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT05155059 is a Phase 2 study of Functional Movement Disorder that is active but no longer recruiting, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155059, a Phase 2 study of Functional Movement Disorder, is active but no longer recruiting, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) measures abnormal movements in 7 body regions as well as gait and speech. Symptom severity in each body region is rated from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) and duration from 0 to 3 (0=none; 1=occasionally, 2=frequent, 3= constant). All severity and duration scores are added to yield a total score. The total score ranges from minimum 0 to maximum 68, high score representing worse outcome.
Conditions Studied
Interventions
- OTHER Sham Comparator
- DEVICE MagStim
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-05-06 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT05155059 still lists
NCT05155059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Functional Movement Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.
NCT05155059 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05155059 about?
NCT05155059 is a clinical study titled "Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders". 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 stimulati...
What is the current status of trial NCT05155059?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-05-06. Estimated completion is 2026-12-01.
What conditions does trial NCT05155059 study?
This clinical trial studies the following conditions: Functional Movement Disorder.
What interventions are being tested in trial NCT05155059?
The interventions under investigation include: Sham Comparator (OTHER), MagStim (DEVICE).
Who is sponsoring clinical trial NCT05155059?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05155059 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05155059's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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