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| Name | Class |
|---|---|
| Suzhou Sceneray Medical Co. , Ltd | INDUSTRY |
| Beijing Pins Medical Co., Ltd | INDUSTRY |
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The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSA-STN | Experimental | Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. |
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| STN-PSA | Experimental | Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | active DBS with optimal stimulating parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months | 5 months | |
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months | 5 months | |
| Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months | 7 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianyou Li, MD, PhD | Contact | +0086-021-64370045 | ldy11483@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dianyou Li, MD, PhD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Change from baseline Mini-Mental Status Exam to 5 months |
| 5 months |
| Change from baseline Mini-Mental Status Exam to 7 months | 7 months |
| Change from baseline Beck depression inventory to 5 months | 5 months |
| Change from baseline Beck depression inventory to 7 months | 7 months |
| Adverse events | up to 12 months after surgery |