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Tics are the hallmark symptoms in Tourette Syndrome. Patients with Tourette Syndrome have difficulties controlling unwanted movements. The ability to control the motor system involves the pre-supplementary motor area (pre-SMA) in the brain. In this study, we will use Transcranial Magnetic Stimulation to modulate the pre-SMA and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive TMS | Experimental | Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive TMS | Device | Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stop Signal Reaction Time (SSRT) | SSRT measured from modified Slater-Hammel stop signal task performance. The SSRT is calculated by subtracting the average stop signal delay (msec) from the average go-trial reaction time. The SSRT is a measure of inhibitory behavior. The lower the SSRT value means a person is better at inhibitory control. The higher the SSRT value means a person is worse at inhibitory control. | 30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve W. Wu, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Repetitive TMS | Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Repetitive TMS | Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stop Signal Reaction Time (SSRT) | SSRT measured from modified Slater-Hammel stop signal task performance. The SSRT is calculated by subtracting the average stop signal delay (msec) from the average go-trial reaction time. The SSRT is a measure of inhibitory behavior. The lower the SSRT value means a person is better at inhibitory control. The higher the SSRT value means a person is worse at inhibitory control. | Posted | Mean | Standard Deviation | milliseconds | 30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Repetitive TMS | Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve W. Wu, M.D. | Cincinnati Children's Hospital Medical Center | 513-636-4222 | steve.wu@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2020 | Mar 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yale Global Tic Severity Scale | The score presented is the total tic severity score, ranging from 0 to 50. A score of 0 is when someone has no tics. A score of 50 is the maximal score for someone with multiple severe tics. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |