Parkinson's Disease
Conditions
Keywords
deep brain stimulation, subthalamic nucleus
Brief summary
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
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: 1. Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement. 2. To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus. 3. To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus 4. To study social functioning of patients after STN-DBS and quality of life of patient caregivers
Interventions
PROCEDUREDeep brain stimulation of the subthalamic nucleus
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.
Sponsors
South-Eastern Norway Regional Health Authority
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of the motor score of the New-UPDRS (part III) OFF medication | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 of Clinical Dyskinesia Rating Scale score | 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 |
| Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life) | 12 months |
Countries
Norway
Outcome results
None listed