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Randomized double-blind multicenter trial comparing bilateral subthalamic nucleus Deep Brain Stimulation (DBS) and bilateral globus pallidus DBS for advanced Parkinson’s disease.


- candidate number2350
- NTR NumberNTR827
- ISRCTNISRCTN85542074
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR3-dec-2006
- Secondary IDsWAR05-0203 
- Public TitleRandomized double-blind multicenter trial comparing bilateral subthalamic nucleus Deep Brain Stimulation (DBS) and bilateral globus pallidus DBS for advanced Parkinson’s disease.
- Scientific TitleSubthalamic nucleus DBS versus globus pallidus DBS for advanced Parkinson’s disease.
- ACRONYMN-STAPS
- hypothesisAssuming that the effects on Parkinson's disease symptoms and dyskinesias, and the rates of procedure-related and device-related complications are almost equal, then continuous bilateral GPi DBS may produce greater functional improvement than bilateral STN stimulation in Parkinson's disease, because the latter is associated with long-term cognitive, mood, and behavioral problems.
- Healt Condition(s) or Problem(s) studiedParkinson's disease
- Inclusion criteriaIdiopathic Parkinson's disease and—despite optimal pharmacological treatment—at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia.
- Exclusion criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate31-dec-2009
- Target number of participants128
- InterventionsStereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus.
- Primary outcomeThe 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). 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. Outcome measurements will be performed at baseline and 12 months after surgery.
- Secondary outcomeSecondary 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.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Rob M.A. Bie, de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Rob M.A. Bie, de
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Prinses Beatrix Fonds
- PublicationsN/A
- Brief summaryPatients with advanced Parkinson’s disease (PD) and long-term pharmacologic treatment often have response fluctuations and dyskinesias. Frequently they cycle between episodes with parkinsonism associated with severe disability (‘off’ phase) and episodes with good mobility (‘on’ phase), usually with dyskinesias. Continuous bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) is an effective surgical treatment for patients with advanced PD who have severe limitations in functioning despite optimal pharmacologic treatment. Recently however, the concerns about STN DBS and adverse effects are increasing, especially for the cognitive, mood, and behavioral features. We hypothesize that bilateral globus pallidus internus (GPi) DBS produces greater functional improvement in PD than bilateral STN DBS because of a lower rate of complications. The study will be a randomized, multicenter, double-blind trial comparing continuous bilateral GPi DBS with bilateral STN DBS in advanced PD. We will enroll 128 patients with advanced PD who have—despite optimal pharmacological treatment—at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia. Patients will be randomly assigned to bilateral GPi DBS or bilateral STN DBS. Baseline and outcome measurements at 12 months will be done in standardized off and on phases. 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). Secondary outcome consists of symptom scales, activities of daily living scales, a quality of life questionnaire, adverse effects, and medication use. Additionally, patients will undergo an extensive neuropsychological and a standardized psychiatric assessment. Five centers in the Netherlands performing functional stereotactic neurosurgery will participate.
- Main changes (audit trail)
- RECORD3-dec-2006 - 19-jan-2007


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