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…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
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.
Study objective
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.
Study burden and risks
There are no direct benefits for the patient. A potential risk is simulator
sickness (similar to car sickness) during the driving simulator test.
Participants are notified of this possibility beforehand and will be monitored
during the test. They will also be informed of their right to stop the test at
any time. A general risk is that assessments (neuropsychological assessment and
driving simulator assessment) can be too demanding for patients; however,
neuropsychologists carrying out the assessments are experienced in testing
vulnerable patients and will carefully check whether the assessments are too
demanding, and quit if necessary. Performance on any of the assessments does
not have legal consequences for the participant*s fitness to drive.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | In afwachting |
| CCMO | NL73666.042.20 |
| OMON | NL-OMON20215 |