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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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In this single-center trial, we aim to include 8 patients with severe and medically refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. Tic severity and secondary outcome measurements are assessed six and twelve months after surgery. Additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and clinicians are blinded to treatment allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On condition | Active Comparator | Ongoing thalamic deep brain stimulation |
|
| Off condition | Sham Comparator | Switched off thalamic deep brain stimulation, sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Deep brain stimulation of the thalamus, Medtronic Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Global Tic Severity Scale (YGTSS) | Motor tic subscore range 0-25 Vocal tic scubscore range 0-25 Impairment range0-50 Total Score (Vocal tic score + Motor tic score + Impairment) range 0-100 Higher Scores indicate higher tic severity, thus worse outcome | Change in the YGTSS Scale from Baseline to 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rush video rating scale (MRVRS) | Range 0-20 Higher Scores indicate higher tic severity, thus worse outcome | Change in the MRVRS Scale from Baseline to 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Kuhn, MD | University Hospital of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cologne | Cologne | 50924 | Germany |
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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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A pragmatic trial with brief randomized, double-blinded sham controlled sequences
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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 |