Early Versus Late Application of STN DBS to PD Patients With Motor Complications

Study Overview
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Brief Summary
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Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is lacking. This study is intended to demonstrate that early, compared with delayed, introduction of STN DBS is more beneficial for PD patients who have developed motor complications.

Detailed Description
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In this prospective study, 200 PD patients will be recruited for STN DBS over three years, including 133 with motor complications existing for more than three years (late complication group) and 67 less than three years (early complication group). To make a comparison of therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed using specific rating scales and questionnaires.

Official Title
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Early Versus Late Application of Subthalamic Deep Brain Stimulation to Parkinson's Disease Patients With Motor Complications: a Multicentre, Prospective and Observational Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Bilateral deep brain stimulation of the subthalamic nucleus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge) Presence of fluctuations and/or dyskinesias Age ranging from 18 to 75 years old Normal brain MRI Absence of dementia (Mini Mental State Examination ≥ 26) Absence of severe psychiatric diseases Written informed consent Exclusion Criteria: Presence of severe metabolic diseases Severe cardiac/respiratory/renal/hepatic diseases Secondary parkinsonism or multiple system atrophy Illiteracy or insufficient language skills to complete the questionnaires Poor compliance and unreasonable expectation Women who are pregnant or breast feeding Simultaneous participation in another clinical trial

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Motor Complication<br>This group is composed of PD patients with motor complications of 3 years or less. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment. | Device: Bilateral deep brain stimulation of the subthalamic nucleus<br> <br> * Other names: Activa PC or RC neurostimulator, Medtronic;|
| Late Motor Complication<br>This group is composed of PD patients with motor complications of more than 3 years. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment. | Device: Bilateral deep brain stimulation of the subthalamic nucleus<br> <br> * Other names: Activa PC or RC neurostimulator, Medtronic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores | Quality of life | From baseline to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores | Motor function | From baseline to 4 years | 
| Changes in time spent in the on state without troubling dyskinesia based on Parkinson's disease home diary | Good on time | From baseline to 4 years | 
| Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores | Motor and non-motor experiences of daily living | From baseline to 4 years | 
| Severe adverse effects | Safety profile | From baseline to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, deep brain stimulation, subthalamic nucleus, motor complication, quality of life