Primary objectives:- To investigate possible differences in driving performances between premanifest gene carriers, manifest HD, and control subjects.- To explore if different aspects of cognitive functioning might be a predictor of fitness to drive…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end-points:
- difference between the groups in number of errors on the outcome variables of
the driving simulator.
- difference between the groups in scores on the neuropsychological and motor
assessments.
Outcome measures:
Driving simulator
- Standard Deviation of Lateral Position (SDLP)
- Mean, maximum and standard deviation of vehicle speed
- Velocity, acceleration, position on the road, right of way, distance to
preceding car, time to collision
Neuropsychological and behavioural assessments
- SDMT: total number of correct responses in 90 seconds
- Stroop: total number of correct responses per trial
- TMT: completion time in seconds for each trial
- SART: the total number of errors
- Adaptive tracking task: average performance (%)
- PBA-s: total score per domain defined as severity multiplied by frequency
Motor assessments
- UHDRS TMS: total motor score (range 0-124)
- UHDRS TFC: total functional score (range 0-13)
- Finger tapping: mean tapping rate and standard deviation
- Saccadic eye movements: saccadic reaction time (seconds), saccadic peak
velocity (degrees/second), saccadic inaccuracy (%)
- Smooth pursuit eye movements: percentage of time the eyes are in smooth
pursuit of the target (%)
- Body sway: antero-posterior sway (mm)
Questionnaires and evaluation
- FrsBe: overall total score and total score per subscale
- HADS-SIS: total scores per domain
- Evaluation: grade given by patient and companion
Secondary outcome
Secondary end-points:
- a correlation between behavioural changes, as measured using the PBA-s, and
driving capacities.
- difference between a patient*s self-appraisal about their driving skills, a
companion's appraisal, and the performance on the simulator and
neuropsychological assessments.
Background summary
Huntington*s disease (HD) is an autosomal dominant inherited neurodegenerative
disorder that is characterized by a triad of symptoms including motor
disturbances, cognitive dysfunction and psychiatric symptoms. Quality of life
and functional ability are strongly affected by cognitive impairments.
Occupational decline and inability to drive safely are most frequently reported
by HD patients and companions. Driving requires multiple complex actions and
optimal cognitive functioning, and is therefore challenging for patients with
HD. However, studies on driving capacities in HD are still scarce and methods
are heterogeneous. Premanifest gene carriers and early stage HD patients often
have questions for the physician regarding their driving skills and are most
likely in need of a driving evaluation in the near future, yet none of the
research has evaluated fitness to drive in these groups.
Study objective
Primary objectives:
- To investigate possible differences in driving performances between
premanifest gene carriers, manifest HD, and control subjects.
- To explore if different aspects of cognitive functioning might be a predictor
of fitness to drive in HD gene carriers across multiple disease stages.
- To investigate the possible association between motor functioning and driving
capacities.
Secondary objectives:
- To investigate the possible relationship between behavioural changes and
driving capacities.
- To investigate if there is a relationship between a patient*s self-appraisal
about their driving skills, companion appraisals, and the performance on the
driving simulator and cognitive assessments.
Study design
This is a prospective, cross-sectional, observational study in HD gene carriers
across multiple disease stages and healthy individuals who are not at risk for
HD.
Study burden and risks
This is an observational study without any intervention, so there are no
specific risks for the participants. The burden is limited to a minimum. All
the assessments are performed during one visit.
Zernikedreef 8
Leiden 2333 CL
NL
Zernikedreef 8
Leiden 2333 CL
NL
Listed location countries
Age
Inclusion criteria
All eligible subjects must meet the following inclusion criteria:
- be at least 18 years of age;
- possess a valid Dutch driver's licence;
- driven at least 300 km in the 12 months prior to study entry, to ensure regular driving activity.;Additional inclusion criteria HD manifest subjects
- confirmed CAG expansion of *36 in the HTT gene;
- UHDRS TMS >5.;Additional inclusion criteria for HD premanifest gene carriers
- confirmed CAG expansion of *36 in the HTT gene;
- UHDRS TMS *5, and no diagnosis in any other HD related domain (i.e. cognition or psychiatric).;Additional inclusion criteria for control subjects
- Gene negative for HD or no family history of HD, preferably spouses or relatives of HD subjects.
Exclusion criteria
All eligible subjects must meet none of the following exclusion criteria:
- Major comorbidities that are unrelated to HD (i.e. isolated psychiatric disorder, other neurological disorder, paralysis, ophthalmic disorder);
- Drug use (i.e. not medication) in the past 3 till 4 weeks prior to the visit day;
- Alcohol abuse (i.e. 3 or more glasses per day);
- Participation in intervention/clinical trials;
- Any other condition that in the opinion of the investigator warrants exclusion of the study.
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 |
|---|---|
| CCMO | NL55414.058.15 |