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NCT03263013 · ClinicalTrials.gov registry record
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 7
- Enrollment target
NCT03263013: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT03263013 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263013 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
Background: Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers want to better understand how the brain works to cause these symptoms. Objective: To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD symptoms. Also, to look at the effect of iTBS on mood and motor symptoms. Eligibility: Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190 Design: Participants will have 4 visits. In Visit 1, participants will be screened with: Medical history Physical exam Urine test Questionnaires Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder surrounded by a strong magnetic field. They will lie on a table that can slide in and out of the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI scan. Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours apart. These include: Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while participants receive magnetic stimulation of the brain. Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse to stimulate the brain. During iTBS, participants will sit quietly and watch a nature documentary. They will wear earplugs and a cap. MRI Functional MRI Questionnaires
Primary Outcome
Percent of subjects experiencing adverse events (i.e., seizures, etc.)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2020-02-05 |
What the finished NCT03263013 record still lists
NCT03263013 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03263013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03263013 about?
NCT03263013 is a clinical study titled "Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders". Background: Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers want to better understand how the brain works to cause these symptoms. Objective: To test if interm...
What is the current status of trial NCT03263013?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2018-03-29. Estimated completion is 2020-02-05.
Who is sponsoring clinical trial NCT03263013?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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