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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR827 |
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Date of registration:
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03/12/2006 |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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Subthalamic nucleus DBS versus globus pallidus DBS for advanced Parkinson?s disease. - N-STAPS |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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128 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=827 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Rob M.A.
Bie, de |
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Address:
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Academic Medical Center (AMC), Department of Neurology, H2-236,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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r.m.debie@amc.uva.nl |
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Affiliation:
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Name:
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Rob M.A.
Bie, de |
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Address:
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Academic Medical Center (AMC), Department of Neurology, H2-236,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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r.m.debie@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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Stereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus.
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Primary Outcome(s)
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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).
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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN85542074
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WAR05-0203
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Source(s) of Monetary Support
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Prinses Beatrix Fonds
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