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 tremor-dominant Parkinson's disease (PD) 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 tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 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
27
active DBS with optimal stimulating parameters
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
in the off-medication condition
Time frame: up to 6 months
Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Timed up and go test (TUG) to the end of STN stimulation phase in the randomization phase
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in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase
in the off-medication condition
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline dysphonia severity index to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Mini-Mental Status Exam to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of PSA stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase
Time frame: up to 6 months (4-6 months depending on randomization arm)
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase
in the off-medication condition
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase
in the off-medication condition
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase
in the off-medication condition
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase
in the off-medication condition
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the 39-item Parkinson's disease questionnaire in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase
Time frame: up to 6 months
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase
Time frame: up to 6 months
Adverse events
Time frame: up to 12 months after surgery