No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease, Deep Brain Stimulation, Parkinson's disease dementia (PDD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success to STN DBS is quantified as the difference in MDS-UPDRS
motor scores measured during an acute stimulation challenge
Secondary outcome
Psychotic symptoms in the 72 hours following surgery, measured by DOS
Global satisfaction with surgery scale
SENS-PD composite score
MDS-UPDRS motor score
Cognitive decline 12 months after surgery
Background summary
Deep Brain Stimulation (DBS) of the Subthalamic Nucleus (STN) is an effective treatment for advanced Parkinson’s Disease. However, there is an increasing need to predict which patients fully benefit from DBS-STN and which will not. In a multi-center observational setting, patients undergoing DBS-STN will receive extensive motor- and non-motor assessments which can be used as potential predictors of 1-year post-operative functioning. We aim to develop a prediction model of success to DBS-STN, i.e. improvement of motor function, which ultimately aims to optimize patient selection for surgery.
Study objective
We expect to develop a robust predictive model with which to identify patients who are most likely to benefit from STN-DBS, thereby optimizing the screening procedure for DBS.
Study design
STN-DBS screening (prior to surgery)
Up to 72 hours post-surgery
One year post-surgery
Intervention
No intervention is formally tested. Patients eligible for STN-DBS after routine screening in the DBS centres will be operated on according to standard procedures. Questionnaires and rating scales will be used for evaluation og the oucomes
M.F. Contarino
Albinusdreef 2
Leiden 2333ZA
The Netherlands
Tel: 0031(0)7171 526 3964
Email: m.f.contarino@lumc.nl
M.F. Contarino
Albinusdreef 2
Leiden 2333ZA
The Netherlands
Tel: 0031(0)7171 526 3964
Email: m.f.contarino@lumc.nl
Inclusion criteria
Age > 18 years
Diagnosis of idiopathic Parkinson's disease
Clinical indication for STN-DBS at the participating centres
Ability to give informed consent
Ability to comply with the study assessments
Ability to read or understand Dutch
Exclusion criteria
Exclusion criteria (contra-indications) for STN-DBS:
Parkinson's disease severity: HY stage 5
Score on Mattis Dementia Rating scale <120
Psychiatric contraindications for STN-DBS
General contra-indications for stereotactic surgery and/or general anaesthesia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6079 |
| NTR-old | NTR6226 |
| CCMO | NL ABR 58679 |