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

NCT ID: NCT04660500

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2023-08-31

Brief 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PD Drivers Using AV Technologies On-road

Each driver will drive on-road, everybody will be exposed to two drives (Drive 1, Drive 2) one drive with and the other without in-vehicle technology. The order of technology (with vs. without IVIS or ADAS) and the order of the routes (Drive 1 vs. Drive 2) will be randomly allocated to control for order effects.

Group Type: EXPERIMENTAL

PD Drivers Using AV Technologies On-road

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherrilene Classen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Countries

United States

References

Classen S, Li Y, Giang W, Winter S, Wei J, Patel B, Jeghers M, Gibson B, Rogers J, Ramirez-Zamora A. RCT protocol for driving performance in people with Parkinson's using autonomous in-vehicle technologies. Contemp Clin Trials Commun. 2022 Jun 28;28:100954. doi: 10.1016/j.conctc.2022.100954. eCollection 2022 Aug.

Reference Type: DERIVED

PMID: 35812823 (View on PubMed)

Other Identifiers

90IFRE0035-03-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB202002321

Identifier Type: -

Identifier Source: org_study_id