The primary objective of this study is to establish a cut-off score on the MoCA, with a high, preferably 100%, sensitivity and reasonable specificity (>70%), in order to identify patients who will fail the CBR assessment, being unfit to drive. .…
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 a cut-off score on the MoCA which has high,
preferably 100% sensitivity and reasonable specificity (>70%) in predicting the
failure on the CBR on-road driving assessment.
Secondary outcome
The study sample will be divided into a pass and fail group, based on the
on-road driving assessment. Groups will be compared in terms of age, disease
severity, and performance on motor-, cognitive- and driving simulator tests. In
addition, regression analyses will be used to detect predictors for failing
on-road driving assessment.
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 impairs the execution of complex tasks in daily living, for example
driving a car. Previous research showed that driving ability is diminished in
PD patients. In the Netherlands, the Dutch driving licensing agency (Centraal
Bureau Rijvaardigheidsbewijzen - CBR) takes care of the assessment of driving
ability on-road. Although guidelines exist in Dutch legislation about the
standard timing of this assessment, no screening instruments are available if
patients should be referred to the CBR. Consequently, patients who are
cognitively impaired, and would not pass the CBR assessment, may not be
referred to the CBR, while patients who are still able to drive safely, with no
or minor cognitive impairments, are referred because of the standardized
assessments over time. In this study we want to establish a clear and sensitive
cut-off score on an established cognitive screening instrument, i.e. the
Montreal Cognitive Assessment (MoCA), which will help physicians to decide when
a patient should be referred to the CBR, or to prevent non-referrals and
unnecessary referrals.
Study objective
The primary objective of this study is to establish a cut-off score on the
MoCA, with a high, preferably 100%, sensitivity and reasonable specificity
(>70%), in order to identify patients who will fail the CBR assessment, being
unfit to drive. . If a 100% sensitivity with reasonable specificity (>70%)
cannot be reached using only the MoCA score, clinical- and/or demographic
variables will be added to the model to increase sensitivity/specificity. The
secondary objective is to explore underlying factors determining which PD
patients fail the on-road driving test.
Study design
This study is designed as an observational study of 45 early phase PD patients,
all currently being active drivers.
Study burden and risks
All participants will attend the University Medical Center Groningen (UMCG)
once for neuropsychological assessment, motor assessment and a driving
simulator test. The duration of this session is approximately 3,5 - 4 hours,
including a break of half an hour. Additional breaks will be set at the
patient*s request. The on-road driving test will be scheduled within three
months after the tests in the UMCG, at the participant*s local office of the
CBR. The on-road driving test has a maximum duration of 60 minutes.
Possible benefits of participating in this study are the free assessment of
driving ability and fitness tot drive. Participants who have failed the on-road
driving test are advised to stop driving, however without a legal consequence
for their driving license.
Participants may experience simulator sickness (similar to car sickness) during
the driving simulator test. Participants are notified of this possibility
beforehand and they 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 will cease the assessments
if necessary.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
- 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 FTDr. The website www.rijveiligmetmedicijnen.nl will be used to
check the classification of medication.
- Presence of premorbid pathology, i.e. experienced cerebral infarction or
chronic depression, non-related to Parkinson*s disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | In afwachting |
| CCMO | NL76304.042.21 |