Dutch Parkinson, Cognition and Driving Ability study (DUPARC-drive): An explorative study on driving simulator performance in de novo Parkinson's Disease patients.

Recruiting

Conditions: Parkinson
Parkinson's disease
10028037

Registration Number: NL-OMON49421

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

All subjects:
- Dutch speaking
- In possession of a driver's license
- Active driver, i.e. having driven at least 300 kilometres in the last year
- Age 18 to 75 (participants aged 75 years or over will be excluded)
- Willingness to cooperate and sign written informed consent

Patients:
- diagnosis of Parkinson's disease
- disease duration <3 months, measured after time of diagnosis

Exclusion Criteria

All subjects:
- Suffering from severe motion sickness (risk factor for simulator sickness)
- Use of category III medication

Patients:
- History of dopaminergic medication use
- Presence of premorbid pathology, i.e. experienced cerebral infarction or
chronic depression, non-related to Parkinson's disease.

Healthy controls:
- History of neurological disorders, which may interfere with cognitive
functioning (e.g. recent concussion, previous subarachnoid or intracerebral
haemorrhage, intracranial tumours, epilepsy, ischemic strokes).
- Presence of psychiatric disorders, i.e. depression or psychosis.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be driving simulator performance of de novo PD<br /><br>patients compared to HC, using the standard deviation of the lateral position<br /><br>(SDLP) during Swing Drive part 1 as primary variable. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be other driving simulator variables (e.g. speed,<br /><br>percentage of lane crossing, reaction time to triggered events and number of<br /><br>violations) and the identification of correlates between SDLP and potential<br /><br>predictors, i.e. neuropsychological test scores and motor scores. </p><br>