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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660500
• Other study ID #: IRB202002321
• Secondary ID: 90IFRE0035-03-00
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subjects diagnosed by a neurologist/ movement disorder specialist with clinically probable PD by Movement Disorders Society (MDS) criteria 25

2. 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

3. 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)

4. Currently driving with a valid license

5. 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)

6. Lives independently in the community

7. Proficient in reading/speaking English

8. A Montreal Cognitive Assessment (MoCA) score of 20 or higher

Exclusion Criteria:

1. Concurrent neurological conditions (e.g., stroke, seizures; dementia)

2. Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions (e.g., missing limbs) precluding full participation

3. Use of psychotropic medications having adverse effect on mental/physical functioning

4. Severe, unpredictable motor fluctuations

5. Severe sleep difficulties.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• PD Drivers Using AV Technologies On-road
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).

Locations

Country	Name	City	State
United States	UF Norman Fixel Institute for Neurological Diseases	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of driving errors	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.	1 year up to study completion
Primary	Type and number of driving errors	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).	1 year up to study completion