Welcome
Support Centre
25 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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.

Please note that as of 15/03/10 this record has been updated to include a second funder (details in the relevanty section below). The end of this trial has been extended from 31/12/2009 to 01/07/2012.
Lay summary Lay summary under review 1
Ethics approval Approval received from the local ethics committee (Medisch Ethische Commissie AMC) on the 17th May 2006 (ref: MEC 06/084 # 07.17.0069). Last amendment approval received on the 11th January 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 (Amended on 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 1. 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 28/11/2012
Date ISRCTN assigned 16/01/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.