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Randomised double-blind multicentre trial comparing bilateral subthalamic nucleus deep brain stimulation and bilateral globus pallidus deep brain stimulation for advanced Parkinson's disease
ISRCTN ISRCTN85542074
DOI 10.1186/ISRCTN85542074
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised double-blind multicentre trial comparing bilateral subthalamic nucleus deep brain stimulation and bilateral globus pallidus deep brain stimulation for advanced Parkinson's disease
Scientific title
Acronym N-STAPS
Serial number at source WAR05-0203
Study hypothesis Assuming 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 Globus Pallidus Deep Brain Stimulation (GPi DBS) may produce greater functional improvement than bilateral SubThalamic Nucleus (STN) stimulation in Parkinson's disease, because the latter is associated with long-term cognitive, mood, and behavioural problems.

On 15/03/2010 this record was updated to include a second funder (details in the relevant section below). The anticipated end date of this trial was changed from 31/12/2009 to 01/07/2012.
Lay summary Background and study aims.
Patients with advanced Parkinsonís disease often do not respond well to medication. When this is the case, deep brain stimulation (DBS) is a treatment option to improve stiffness, shaking and slowness. DBS is a type of surgery in which two electrodes are placed deep in the brain: one on each side of the brain. These electrodes transmit a current that relieves symptoms. This can be done in a brain area called the subthalamic nucleus (STN) or in an area called the globus pallidus (GPi). This study compares the effects of DBS of the STN with DBS of the GPi.

Who can participate?
Patients with Parkinsonís disease suffering from uncontrollable involuntary movements, pain, or severe slowness can participate.

What does the study involve?
Patients are randomly allocated to receive DBS of either the STN or the GPi. Afterwards, they are followed extensively, for up to 5 years, to monitor the effects on motor symptoms, mental status, and behavior.

What are the possible benefits and risks of participating?
Both STN DBS and GPi DBS are already established treatment options for advanced PD. Risks of surgery include hemorrhage (bleeding), infection and malfunctioning of the equipment.

Where is the study run from?
The study is run from the Academic Medical Center, Amsterdam, The Netherlands. Four other centers in the Netherlands have participated

When is the study starting and how long is it expected to run for?
Patient recruitment ran from January 2007 until May 2012.

Who is funding the study?
Stichting Internationaal Parkinson Fonds, Prinses Beatrix Fonds, and Parkinson Vereniging (Netherlands).

Who is the main contact?
Rob M A de Bie
r.m.debie@amc.uva.nl
Ethics approval Medisch Ethische Commissie AMC, 17/05/2006, ref: MEC 06/084 # 07.17.0069. Last amendment approval received on 11/01/2007.
Study design Randomised controlled parallel-group double-blinded multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Parkinson's disease
Participants - 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
Participants - exclusion criteria 1. Age below 18 years
2. Previous functional stereotactic neurosurgery
3. Hoehn and Yahr stage five 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)
Anticipated start date 01/01/2007
Anticipated end date 01/07/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 128 (updated 03/05/2012: recruitment completed in April 2011)
Interventions Stereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus.
Primary outcome measure(s) The number of patients with significant cognitive, mood, and behavioural adverse effects and the off-on phase weighted Academic Medical Centre (AMC) Linear Disability Scale (functional improvement).

Significant cognitive, mood, and behavioural 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 three months or longer.

Outcome measurements will be performed at baseline and 12 months after surgery.
Secondary outcome measure(s) Secondary outcome consists of:
1. Symptom scales (Unified Parkinson's Disease Rating Scale [UPDRS] motor, Clinical Dyskinesia Rating Scale [CDRS])
2. Activities of daily living scales (ADLS) and UPDRS Activity of Daily Living (ADL) scale
3. A quality of life questionnaire (Parkinsons Disease Quality of Life [PDQL])
4. Adverse effects
5. Medication use

Additionally, patients will undergo extensive neuropsychological and standardised psychiatric assessment.
Sources of funding 1. Prinses Beatrix Fonds (Netherlands)
2. Internationaal Parkinson Fonds (Netherlands)
Trial website
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23168021
Contact name Dr  Rob M A  de Bie
  Address Academic Medical Center (AMC)
Department of Neurology, H2-236
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Email r.m.debie@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 16/01/2007
Last edited 15/08/2014
Date ISRCTN assigned 16/01/2007
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