PSA Versus STN DBS for TD-PD

Study Overview
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Brief Summary
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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 tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Detailed Description
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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.

Official Title
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Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Deep brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSA-STN<br>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. | Device: Deep brain stimulation<br>* active DBS with optimal stimulating parameters<br>|
| Experimental: STN-PSA<br>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. | Device: Deep brain stimulation<br>* active DBS with optimal stimulating parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months | in the off-medication condition | 4 months | 
| Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months | in the off-medication condition | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months |  | 4 months | 
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months |  | 6 months | 
| Change from baseline Timed up and go test to 4 months | in the off-medication condition | 4 months | 
| Change from baseline Timed up and go test to 6 months | in the off-medication condition | 6 months | 
| Change from baseline Berg balance scale to 4 months | in the off-medication condition | 4 months | 
| Change from baseline Berg balance scale to 6 months | in the off-medication condition | 6 months | 
| Change from baseline 39-item Parkinsons disease questionnaire to 4 months |  | 4 months | 
| Change from baseline 39-item Parkinsons disease questionnaire to 6 months |  | 6 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 maximal phonatory time to 4 months |  | 4 months | 
| Change from baseline maximal phonatory time to 6 months |  | 6 months | 
| Change from baseline dysphonia severity index to 4 months |  | 4 months | 
| Change from baseline dysphonia severity index to 6 months |  | 6 months | 
| Change from baseline Mini-Mental Status Exam 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 | 
| Adverse events |  | up to 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tremor-dominant Parkinson's disease, deep brain stimulation, posterior subthalamic area, subthalamic nucleus