Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

Study Overview
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Brief Summary
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This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic . The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of personalization of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

Official Title
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Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: patients with Parkinson's disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation Bilateral STN stimulation considered Patient able to provide their free and informed consent Patient with insurance coverage Exclusion Criteria: Atypical Parkinson's disease do not meet the criteria of stuff . MP under 5 years Severe cognitive impairment or dementia ( Score Moca <24 and DSM-IV criteria) Parkinson's Psychosis Reply to L- dopa <30 % Against indication for surgery Severe brain atrophy or abnormal MRI The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .

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 |
| --- | --- |
| patients with Parkinson's disease<br>Large population of Parkinson's patients who benefit from subthalamic stimulation | Other: patients with Parkinson's disease<br> <br> * Other names: systematic and standardized collection of data;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve of quality of life on PDQ39>20% |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of motor score MDS-UPDRS III improve under stimulation |  | 1 year | 
| Socio-familial evolution (institutionalization) |  | 1, 3 and 5 years | 
| Clinical Global Impression of Patient by 7-point scale | with the CGI-scale | 1, 3 and 5 years | 
| Clinical Global Impression of doctor by 7-point scale | with the CGI-scale | 1, 3 and 5 years | 
| Death |  | 1, 3 and 5 years | 
| Cognitive function with a neuropsychological examination | with Mattis scale, Wisconsin Card Sorting test, Stroop test, , verbal episodic memory test with 16 items, phonemic and semantic verbal fluency, Boston naming test (15 items), clock drawing and Benton line orientation task | 1, 3 and 5 years | 
| Behavior test | ECMP scale of Ardouin 2009, Hamilton depression scale, Anxiety Hamilton scale, Lille Apathy Rating Scale, QUIP questionnaire, Billieux Impulsivity Scale, Hallucination questionnaire of Miami | 1, 3 and 5 years | 
| Motor response rates to Levodopa | with the difference of the motor handicap measured by MDS UPDRS part III before and after an acute L-dopa challenge | 1, 3 and 5 years | 
| Non-motor functions evaluated by a numerical evaluation scale |  | screening and at 1, 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subthalamic neurostimulation