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 | https://doi.org/10.1186/ISRCTN85542074 |
| Secondary identifying numbers | WAR05-0203 |
- Submission date
- 16/01/2007
- Registration date
- 16/01/2007
- Last edited
- 04/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Academic Medical Center (AMC)
Department of Neurology, H2-236
PO Box 22660
Amsterdam
1100 DD
Netherlands
| r.m.debie@amc.uva.nl |
Study information
| Study design | Randomised controlled parallel-group double-blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | N-STAPS |
| Study objectives | 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(s) | Medisch Ethische Commissie AMC, 17/05/2006, ref: MEC 06/084 # 07.17.0069. Last amendment approval received on 11/01/2007. |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Stereotactic bilateral implantation of DBS electrodes in the globus pallidus internus or the nucleus subthalamicus. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/01/2007 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1100 DD
Netherlands
Sponsor information
Hospital/treatment centre
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 23/02/2016 | Yes | No |
Editorial Notes
04/07/2016: Publication reference added.
15/03/2010: this record was updated to include a second funder (details in the relevant section below). The overall trial end date was changed from 31/12/2009 to 01/07/2012.
