De novo Parkinson's patients already present with declined driving ability at time of diagnosis, compared to age- and sex matched healthy controls.
ID
Source
Brief title
Health condition
Parkinson's disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Driving simulator performance of de novo PD patients compared to HC, using the SDLP during Swing Drive part 1.
Secondary outcome
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.
Background summary
Parkinson’s disease (PD) is a complex neurodegenerative disease, with cognitive impairment being one of the most important non-motor symptoms. Cognitive decline can impair the execution of many complex tasks in daily activities, for example driving a car. It is established that driving ability is diminished in PD patients, in which a decline in cognitive functioning is an important factor. However, cognitive decline can also precede motor manifestations of PD by years, suggesting that recently diagnosed de novo PD patients might already be at risk for unsafe driving. The proposed study will be the first study to explore driving ability in de novo, treatment-naïve PD patients. The primary objective of this study is to study whether driving ability may be affected in de novo, treatment naïve PD patients, by comparing their driving simulator performance to age- and sex-matched healthy controls (HC). The secondary objective is to explore neuropsychological- and motor variables that may correlate with driving simulator performance at time of diagnosis. Study design: This study is designed as an explorative study of 30 de novo PD patients and 30 sex- and age matched healthy controls (HC), all currently active drivers. Patients and HC will undergo neuropsychological assessment and driving simulator assessment. The primary endpoint will be driving simulator performance of de novo PD patients compared to HC, using the standard deviation of the lateral position (SDLP) during Swing Drive part 1 as primary variable. Secondary endpoints 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.
Study objective
De novo Parkinson's patients already present with declined driving ability at time of diagnosis, compared to age- and sex matched healthy controls.
Study design
Cross-sectional
Intervention
N/A
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).
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8727 |
| CCMO | NL73666.042.20 |
| OMON | NL-OMON49421 |