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

Conditions: Parkinson's disease

Registration Number: NL-OMON20215

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

All subjects:
-Dutch speaking
-In possession of a driver’s license
-Active drivers, i.e., having driven at least 300 kilometres in the last year
-Age 18 to 75
-Willingness to cooperate and sign written informed consent

De novo PD subjects:
-Diagnosis Parkinson’s disease, as confirmed by a neurologist specialized in Parkinson’s Disease, by the UK-Brain Bank Criteria.
-Disease duration < 3 months, measured after time of diagnosis.

Exclusion Criteria

All subjects:
-Suffering from severe motion sickness; motion sickness is a risk factor for simulator sickness.
-Use of category III medication.

De novo PD subjects:
-History of dopaminergic medication use.
-Presence of premorbid pathology, i.e. experienced cerebral infarction or chronic depression, non-related to Parkinson’s disease.

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Driving simulator performance of de novo PD patients compared to HC, using the SDLP during Swing Drive part 1.

Secondary Outcome Measures

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