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OPTIMIzing patient selection for deep brain STimulation of the subthalamic nucleus in Parkinsonís disease: the OPTIMIST study


- candidate number26531
- NTR NumberNTR6226
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2017
- Secondary IDsNL ABR 58679 
- Public TitleOPTIMIzing patient selection for deep brain STimulation of the subthalamic nucleus in Parkinsonís disease: the OPTIMIST study
- Scientific TitleOPTIMIzing patient selection for deep brain STimulation of the subthalamic nucleus in Parkinsonís disease: the OPTIMIST study
- ACRONYMOPTIMIST study
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Deep Brain Stimulation (DBS)
- Inclusion criteriaAge > 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 criteriaExclusion 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 31-jan-2017
- planned closingdate30-jan-2019
- Target number of participants83
- InterventionsNo 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
- Primary outcomeSuccess to STN DBS is quantified as the difference in MDS-UPDRS
motor scores measured during an acute stimulation challenge
- Secondary outcomePsychotic 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
- TimepointsSTN-DBS screening (prior to surgery)
Up to 72 hours post-surgery
One year post-surgery
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD M.F. Contarino
- CONTACT for SCIENTIFIC QUERIESMD, PhD M.F. Contarino
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Parkinson Fonds
- Publications
- Brief summaryDeep Brain Stimulation (DBS) of the Subthalamic Nucleus (STN) is an effective treatment for advanced Parkinsonís 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.
- Main changes (audit trail)
- RECORD24-jan-2017 - 29-apr-2017


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