Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03263013|
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : February 7, 2020
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.
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.
Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190
Participants will have 4 visits.
In Visit 1, participants will be screened with:
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.
|Condition or disease|
The purpose of this protocol is to investigate feasibility and safety of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). We further aim at exploring whether iTBS of the DLPFC modulates amygdala activity, by investigating iTBS effects on resting-state fronto-amygdala connectivity and on amygdala BOLD response to valenced stimuli.
FMD patients (N=6), aged 18-65 years, admitted at the Human Motor Control Section (HMCS) clinic, who have completed protocol 07-N-0190.
Participants will undergo four outpatient visits. On Visit #1 (baseline), patients will undergo a screening session to assess their eligibility to participate in the current study. They will undergo neurological and psychiatric assessment, as well as structural and functional magnetic resonance imaging. Intermittent TBS will be performed on three separated visits (Visit #2, #3 and #4; iTBS1, iTBS 2 and iTBS 3). During each visit, participants will receive three iTBS sessions over 1-hour, with a 15-minute interval between sessions. Each session will last 190 seconds and a total of 600 pulses will be delivered. Magnetic field intensity will be set at 120% of that participants observed daily resting motor threshold. The target will be identified using the neuronavigation system Brainsight. Following each iTBS visit, behavioral and functional imaging data will be collected.
Our primary outcomes will be to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD. In addition, in order to investigate amygdala engagement by DLPFC iTBS, the following exploratory outcomes will be analyzed: (1) Amygdala BOLD signal change in response to valenced stimuli, from baseline to iTBS3; (2) Amygdala BOLD signal change in response to valenced stimuli, from baseline to each timepoint (iTBS1- iTBS3), for each valence stimuli; (3) Change in fronto-amygdalar resting state functional connectivity, from baseline to iTBS3 (z-score); (4) Change in fronto-amygdalar resting state functional connectivity from baseline to each time point (iTBS1- iTBS3); (5) Change in the valence and arousal subjective levels, using the self-assessment Manikin, from baseline to each time point (iTBS1- iTBS3); (6) Correlations of percent amygdala BOLD signal change with changes in arousal and valence level; (7) Change in the scores on the simplified version of the FMD-RS from pre- to post treatment, for each timepoint.
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Patients With Functional Movement Disorders|
|Actual Study Start Date :||March 29, 2018|
|Actual Primary Completion Date :||February 5, 2020|
|Actual Study Completion Date :||February 5, 2020|
patients with functional movement disorders (FMD)
- to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD. [ Time Frame: baseline, visit 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263013
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|