Optimizing patient selection for deep brain stimulation of the subthalamic nucleus in Parkinson*s disease: the OPTIMIST study
Completed
- Conditions
- Parkinson's diseaseshaking palsy1002803710019190
- Registration Number
- NL-OMON42986
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 83
Inclusion Criteria
- Age >18 years.
- Diagnosis of idiopathic Parkinson's disease according to established criteria.
- Clinical indication for STN DBS at the participating centre.
- Ability to give informed consent.
- Ability to comply with the study assessments.
- Ability to read or understand Dutch.
Exclusion Criteria
There are no specific exclusion criteria for this study other than exclusion criteria that pertain to contra-indications for STN-DBS, which are the following:
- PD severity graded according to Hoehn & Yahr stage 5.
- Score on Mattis Dementia Rating scale <120.
- Psychiatric contraindications to STN DBS.
- General contraindications for stereotactic surgery and general anaesthesia
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint in this study is the response to STN DBS as measured by an<br /><br>acute stimulation challenge performed 12 months after surgery, defined as the<br /><br>percentage change of MDS-UPDRS motor score after overnight medication<br /><br>withdrawal between *off*-stimulation and *on*-stimulation. We will compare the<br /><br>accuracy of the three models (described under Objectives) in predicting this<br /><br>primary endpoint. In all models the effect of pertinent covariates and<br /><br>variability between centres will be taken into account. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- the occurrence of psychotic symptoms in the 72 hours following surgery, as<br /><br>measured by a score >=3 on the delirium observation scale (DOS).<br /><br>- the change in quality of life after surgery, the *Global satisfaction with<br /><br>surgery* scale and the number of contacts (outpatient visits, telephone calls,<br /><br>emails) with the hospital team (neurologists, parkinson nurses) in the first<br /><br>year.<br /><br>- the SENS-PD score and MDS-UPDRS motor score.<br /><br>- the cognitive decline 12 months after surgery, as defined by either a) the<br /><br>transition to mild cognitive impairment or PD-related dementia diagnosed<br /><br>according to criteria proposed by the Movement Disorders Society, or b) a<br /><br>reduction in MoCA score >3 points.</p><br>