Plain English Summary
Background and study aims
Patients with advanced Parkinson's 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 Parkinson's 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rob M A de Bie
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Neurology
H2-236
PO Box 22660
Amsterdam
1100 DD
Netherlands
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r.m.debie@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WAR05-0203
Study information
Scientific 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
Acronym
N-STAPS
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.
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
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Parkinson's disease
Intervention
Stereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/01/2007
Overall trial end date
01/07/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant 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)
Recruitment start date
01/01/2007
Recruitment end date
01/05/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
PO Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Prinses Beatrix Fonds (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Internationaal Parkinson Fonds (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23168021
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26819458
Publication citations
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Results
Odekerken VJ, van Laar T, Staal MJ, Mosch A, Hoffmann CF, Nijssen PC, Beute GN, van Vugt JP, Lenders MW, Contarino MF, Mink MS, Bour LJ, van den Munckhof P, Schmand BA, de Haan RJ, Schuurman PR, de Bie RM, Subthalamic nucleus versus globus pallidus bilateral deep brain stimulation for advanced Parkinson's disease (NSTAPS study): a randomised controlled trial., Lancet Neurol, 2013, 12, 1, 37-44, doi: 10.1016/S1474-4422(12)70264-8.
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Results
Odekerken VJ, Boel JA, Schmand BA, de Haan RJ, Figee M, van den Munckhof P, Schuurman PR, de Bie RM; NSTAPS study group, GPi vs STN deep brain stimulation for Parkinson disease: Three-year follow-up, Neurology, 2016 , 86, 8, 755-761, doi: 10.1212/WNL.0000000000002401.