Status:
UNKNOWN
Effects of Deep Brain Stimulation in Parkinson's Disease
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 method...
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) pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00855621
Start Date
March 1 2009
End Date
December 1 2023
Last Update
November 21 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oslo University Hospital
Oslo, Oslo County, Norway, 0027