Dutch Parkinson, Cognition and Driving Ability study part two (DUPARC-drive 2): A study on fitness to drive in early phase Parkinson*s Disease patients.
- Conditions
- ParkinsonParkinson's disease10028037
- Registration Number
- NL-OMON50941
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
- Diagnosis Parkinson*s disease, as confirmed by a neurologist specialized in
Parkinson*s Disease, by the UK-Brain Bank Criteria.
- Disease duration between 35-60 months, measured after time of diagnosis.
- Active driver
- Own a car or have access to a car
- Age 18 to 75
- Dutch speaking
- Willingness to cooperate and sign written informed consent
- Suffering from severe motion sickness; motion sickness is a risk factor for
simulator sickness.
- Use of category III medication, that may - according to current legislation -
interfere with FTDr. The website www.rijveiligmetmedicijnen.nl will be used to
check the classification of medication.
- Presence of premorbid pathology, i.e. experienced cerebral infarction or
chronic depression, non-related to Parkinson*s disease.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be a cut-off score on the MoCA which has high,<br /><br>preferably 100% sensitivity and reasonable specificity (>70%) in predicting the<br /><br>failure on the CBR on-road driving assessment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The study sample will be divided into a pass and fail group, based on the<br /><br>on-road driving assessment. Groups will be compared in terms of age, disease<br /><br>severity, and performance on motor-, cognitive- and driving simulator tests. In<br /><br>addition, regression analyses will be used to detect predictors for failing<br /><br>on-road driving assessment. </p><br>