Huntington's disease movement disorder
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed