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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
active DBS with optimal stimulating parameters
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGChange from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
Time frame: 5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
Time frame: 7 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months
Time frame: 5 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months
Time frame: 7 months
Change from baseline Mini-Mental Status Exam to 5 months
Time frame: 5 months
Change from baseline Mini-Mental Status Exam to 7 months
Time frame: 7 months
Change from baseline Beck depression inventory to 5 months
Time frame: 5 months
Change from baseline Beck depression inventory to 7 months
Time frame: 7 months
Adverse events
Time frame: up to 12 months after surgery
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