Low-Fidelity Driving Simulator Training in Parkinson's Disease. (NCT07463755) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-Fidelity Driving Simulator Training in Parkinson's Disease.
United States36 participantsStarted 2026-04-15
Plain-language summary
The goal of this clinical trial is to learn if low-fidelity driving simulator training works to improve cognitive performance, driving behavior, and driving aptitude in individuals with Parkinson's disease. The main questions it aims to answer are:
* Does low-fidelity driving simulator training improve cognitive performance?
* Does low-fidelity driving simulator training improve driving performance?
* Does low-fidelity driving simulator training improve driving aptitude?
Researchers will compare driving simulator training to no-training (waitlist control group) to see if the low-fidelity driving simulator is effective in individuals with Parkinson's disease.
Participants will:
* Undergo 10 sessions of driving simulator training or be placed in the no-training group.
* Training group participants will visit the driving simulator lab 2-3 times a week for 4 weeks for training.
* Paper-based tests and driving simulator tests will be done before and after 10 sessions of training (or a waiting period).
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with Parkinson's disease diagnosed by a movement disorder specialist.
* Diagnosis of PD was based on the UK Brain Bank Diagnostic Criteria.
* Hoehn and Yahr stage 1 to 3 in the medication ON state with no troublesome dyskinesia.
* Minimum binocular acuity of 20/40 or better at least in one eye according to the Kansas DMV statutes.
* Montreal Cognitive Assessment (MoCA) ≥ 20.
* Ambulates independently with or without walking aids.
* Possess a valid driver's license.
Exclusion Criteria:
* Any concomitant neurological comorbidity, such as stroke, traumatic brain injury, or multiple sclerosis, that would hinder driving.
* Atypical forms of Parkinsonism
* History of substance abuse in the last 10 years.
* History of uncontrolled psychiatric problems
* Undergone deep brain stimulation or focused ultrasound treatment
* Uncontrolled diabetes mellitus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still listed as 'not yet recruiting' — do you know when it might open for enrollment, and would it make sense to keep it on my radar given where I am in my Parkinson's progression?
2The study is measuring my lane-keeping ability in a driving simulator and my own confidence in my driving skills — based on how my Parkinson's symptoms currently affect my motor control and reaction time, do you think those are areas where I might meaningfully benefit from simulator training?
3Since this trial is listed as Phase NA, which often means it's focused on feasibility or early testing rather than proving a treatment works, what does that mean for how much we can realistically expect to learn about whether this approach actually helps Parkinson's patients drive more safely?
4Before considering something like simulator-based driving training, are there standard occupational therapy or driving rehabilitation programs already available that we should try first, or alongside this trial?
5If I were to take part in this study, how would my participation interact with any decisions about whether it's still safe for me to drive — could the results affect my driving license or my neurologist's recommendations about driving?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Driving performance - Standard Lane Deviation Position
Timeframe: Baseline (pre-intervention) and at 4 weeks (post-intervention)
2
Driving aptitude - The Adelaide Driving Self-Efficacy Scale
Timeframe: Baseline (pre-intervention) and at 4 weeks (post-intervention)