Effects of Deep Brain Stimulation in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.

Detailed Description
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The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment. The study has several aims: Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement. To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus. To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus To study social functioning of patients after STN-DBS and quality of life of patient caregivers

Official Title
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Prognostic Factors in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) - a Prospective Randomized Double-blind Study (The NORSTIM Study)

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Procedure: Deep brain stimulation of the subthalamic nucleus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease Symptoms ≥ 5 years Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs Failure of medical treatment to sufficiently control symptoms L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor Exclusion Criteria: Previous surgery for Parkinson's disease Marked axial motor symptoms unresponsive to treatment with l-dopa Dementia (Mattis dementia rating scale < 130). Patient suffering from untreated moderate or major depression or anxiety disorder Presence of other psychiatric disorder preventing necessary co-operation Brain MRI showing marked atrophy or white matter changes Increased risk of bleeding Presence of medical illness with short life expectancy Other surgical contra-indications

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single microelectrode<br>Surgical procedure performed using single microelectrode recording guidance intraoperatively | Procedure: Deep brain stimulation of the subthalamic nucleus<br>* Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.<br>|
| Active Comparator: Multiple microelectrode<br>Surgical procedure performed using multiple microelectrode recording guidance intraoperatively | Procedure: Deep brain stimulation of the subthalamic nucleus<br>* Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the motor score of the New-UPDRS (part III) OFF medication |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Clinical Dyskinesia Rating Scale score |  | 12 months | 
| Change from baseline in ADL function (UPDRS part II) |  | 12 months | 
| Change from baseline in Mattis Dementia Rating Scale score |  | 12 months | 
| Change in social functioning (Social adjustment scale-SR) |  | 12 months | 
| Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life) |  | 12 months | 
| Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index) |  | 12 months | 
| Frequency of new or worsened psychiatric symptoms |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain stimulation, subthalamic nucleus