Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies

For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help mitigate functional deficits, improve driving performance, decrease driving errors and enhance their ability to stay on the road. Using a pretest/posttest design the investigators will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide recommendations to drivers with PD, the clinical community and industry.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25
Has mild or moderate disease severity, based on the MDS-Unified Parkinson's Disease Rating Scale for motor symptoms (hereafter referred to as the UPDRS section 3) in the on state of medications (i.e., one hour of taking PD medications) and the Modified Hoehn and Yahr disease severity scale
Is representative of one of two PD groups based on age, i.e., participants with symptom onset between 35-64 years of age (younger onset), or participants with symptom onset between ages 65- 85 years (older onset)
Currently driving with a valid license
Meets the Florida state requirement for visual acuity of at least 20/50 in one eye, if one eye is blind or 20/200 or worse the other eye must be 20/40 or better (20/40 in at least one eye) and field of vision (130 degrees or more)
Lives independently in the community
Proficient in reading/speaking English
A Montreal Cognitive Assessment (MoCA) score of 20 or higher

Exclusion criteria

Concurrent neurological conditions (e.g., stroke, seizures; dementia)
Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation
Use of psychotropic medications having adverse effect on mental/physical functioning
Severe, unpredictable motor fluctuations
Severe sleep difficulties.

Treatment and study plan

PD Drivers Using AV Technologies On-road

Other

All drives will include events to assess the impact of in-vehicle information systems (IVIS) and advanced driver assistance systems (ADAS) on the driving performance (driving errors) of drivers with PD. For IVIS the investigators will include options to assess errors with lane maintenance (with and without the lane departure warning system) and signaling (with and without blind spot detection). For ADAS the investigators will include conditions to assess errors in speeding (with and without adaptive cruise control) and lane exceedances (with and without lane keeping assist).

Primary outcomes

Total number of driving errors

Time frame: 1 year up to study completion

The evaluator will record the total number of driving errors by number and type (i.e., speeding, lane maintenance, and signaling) on a standardized data collection form.
Type and number of driving errors

Time frame: 1 year up to study completion

Type of driving errors include: speeding, lane maintenance and signaling on-road recorded by the evaluator, or via vehicle recorded kinematics and telematics (e.g., in-vehicle GPS to record speed).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Dec 9, 2020
Registry last updated: Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed