PSA Versus STN DBS for TD-PD
- Conditions
- Parkinson Disease
- Interventions
- Device: Deep brain stimulation
- Registration Number
- NCT05382858
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- diagnosis of idiopathic Parkinson's disease
- tremor-dominant subtype in the on-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
- receiving regular anti-parkinsonian drugs for more than 6 weeks
- good compliance and written informed consent provided
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
- Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description STN-PSA Deep brain stimulation 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. PSA-STN Deep brain stimulation 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.
- Primary Outcome Measures
Name Time Method Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months 4 months in the off-medication condition
Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months 6 months in the off-medication condition
- Secondary Outcome Measures
Name Time Method Change from baseline Timed up and go test to 6 months 6 months in the off-medication condition
Change from baseline Berg balance scale to 6 months 6 months in the off-medication condition
Change from baseline 39-item Parkinsons disease questionnaire to 6 months 6 months Change from baseline maximal phonatory time to 4 months 4 months Change from baseline Timed up and go test to 4 months 4 months in the off-medication condition
Change from baseline maximal phonatory time to 6 months 6 months Change from baseline Mini-Mental Status Exam to 4 months 4 months Change from baseline Berg balance scale to 4 months 4 months in the off-medication condition
Adverse events up to 12 months after surgery Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months 4 months Change from baseline Levodopa equivalent daily dose to 4 months 4 months Change from baseline Levodopa equivalent daily dose to 6 months 6 months Change from baseline dysphonia severity index to 4 months 4 months Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months 6 months Change from baseline 39-item Parkinsons disease questionnaire to 4 months 4 months Change from baseline Mini-Mental Status Exam to 6 months 6 months Change from baseline Beck depression inventory to 4 months 4 months Change from baseline Beck depression inventory to 6 months 6 months Change from baseline dysphonia severity index to 6 months 6 months
Trial Locations
- Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China