Effects of Deep Brain Stimulation in Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Procedure: Deep brain stimulation of the subthalamic nucleus
- Registration Number
- NCT00855621
- Lead Sponsor
- Oslo University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single microelectrode Deep brain stimulation of the subthalamic nucleus Surgical procedure performed using single microelectrode recording guidance intraoperatively Multiple microelectrode Deep brain stimulation of the subthalamic nucleus Surgical procedure performed using multiple microelectrode recording guidance intraoperatively
- Primary Outcome Measures
Name Time Method Change from baseline of the motor score of the New-UPDRS (part III) OFF medication 12 months
- Secondary Outcome Measures
Name Time Method 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 in Mattis Dementia Rating Scale score 12 months Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index) 12 months Change from baseline of Clinical Dyskinesia Rating Scale score 12 months Change from baseline in ADL function (UPDRS part II) 12 months Frequency of new or worsened psychiatric symptoms 12 months
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway