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ACTIVE NOT RECRUITING Phase 2

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

NCT05155059 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Sham Comparator
  • DEVICE MagStim

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center — Bethesda

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2022-05-06
Est. Completion 2026-12-01
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05155059

The ClinicalTrials.gov registry entry for NCT05155059 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 339 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05155059 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05155059?

The interventions under investigation include: Sham Comparator (OTHER), MagStim (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05155059?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 339 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial