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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29145

Enrollment

Registered

2020-12-17

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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 fitness to drive. - Presence of premorbid pathology, i.e. experienced cerebral infarction or chronic depression, non-related to Parkinson’s disease.

Design outcomes

Primary

Measure	Time frame
A cut-off score on the MoCA, that predicts failing an on-road driving test with high, preferably 100%, sensitivity and reasonable specificity (74%). Results of the MoCA and on-road driving test will be collected at approximately the same time (the on-road driving test will take place within 3 months after the visit to the UMCG).	—

Secondary

Measure	Time frame
The secondary objective is to gain insight in the underlying functions that can cause some PD patients to fail the on-road driving assessment. Secondary outcome measures will be taken into account are: - driving simulator performance (UMCG visit), e.g. standard deviation of the lateral position, speed, percentage of lane crossing, reaction time to triggered events and number of violations; - risk taking behaviour, using neuropsychological test results (UMCG visit) such as the Action Selection Task from the Institute for Road Safety Research (SWOV); - cognitive functioning, using neuropsychological tests that assess functions that are important for fitness to drive (UMCG visit); - motor functioning, using the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (UMCG visit).	—

Measure

Time frame

The secondary objective is to gain insight in the underlying functions that can cause some PD patients to fail the on-road driving assessment. Secondary outcome measures will be taken into account are: - driving simulator performance (UMCG visit), e.g. standard deviation of the lateral position, speed, percentage of lane crossing, reaction time to triggered events and number of violations; - risk taking behaviour, using neuropsychological test results (UMCG visit) such as the Action Selection Task from the Institute for Road Safety Research (SWOV); - cognitive functioning, using neuropsychological tests that assess functions that are important for fitness to drive (UMCG visit); - motor functioning, using the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (UMCG visit).

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Contacts

Public ContactHanna Slomp

University Medical Center Groningen

a.c.slomp@umcg.nl0503614817

Outcome results