Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03263013
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2017-08-25
Brief Title:
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Patients With Functional Movement Disorders
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Objectives
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
Study population
FMD patients N6 aged 18-65 years admitted at the Human Motor Control Section HMCS clinic who have completed protocol 07-N-0190
Design
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
Outcome measures
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
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
Study population
FMD patients N6 aged 18-65 years admitted at the Human Motor Control Section HMCS clinic who have completed protocol 07-N-0190
Design
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
Outcome measures
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-N-0160 | None | None | None |