CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03263013
NCT03263013N/ACompleted

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

National Institute of Neurological Disorders and Stroke (NINDS)·observational·Posted Aug 28, 2017·Updated Jul 22, 2021

In Brief

An observational study for Movement Disorders. Completed, enrolled 7 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 28, 2017
Enrollment StartMar 29, 2018
Primary CompletionFeb 5, 2020
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 8.8 years ago