Randomized double-blind multicenter trial comparing bilateral subthalamic nucleus Deep Brain Stimulation (DBS) and bilateral globus pallidus DBS for advanced Parkinson’s disease.
- Conditions
- Advanced Parkinson's disease
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
Idiopathic Parkinson's disease and—despite optimal pharmacological treatment—at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia.
Exclusion Criteria
1. Age below 18 years;
2. Previous functional stereotactic neurosurgery;
3. Hoehn and Yahr stage 5 at the best moment during the day;
4. A Mattis dementia rating scale score of less than 120;
5. Psychosis, and contraindications for stereotactic neurosurgery such as a physical disorder making surgery hazardous (severe hypertension, blood coagulation disorder, severe dysphagia, or dysphasia).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measures are the number of patients with significant cognitive, mood, and behavioral adverse effects and the off-on phase weighted AMC Linear Disability Scale (functional improvement).<br>Significant cognitive, mood, and behavioral adverse effects are defined as worsening on three or more cognitive tests (based on the reliable change index), or the loss of professional activity/work/job, or the loss of an important relationship (e.g. marriage), or psychosis/depression/anxiety for a period of 3 months or longer.<br>Outcome measurements will be performed at baseline and 12 months after surgery.
- Secondary Outcome Measures
Name Time Method Secondary outcome consists of symptom scales (UPDRS motor, CDRS), activities of daily living scales (ALDS and UPDRS ADL), a quality of life questionnaire (PDQL), adverse effects, and medication use. Additionally, patients will undergo extensive neuropsychological and standardized psychiatric assessment.