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

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04660500
• Collaborator: National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)
• Enrollment: 105
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.5
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: PD Drivers Using AV Technologies On-road	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 105 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
• Actual Study Start Date: Jan 15, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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).

Outcome Measures

Primary Outcome Measures

1. Total number of driving errors [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.

2. Type and number of driving errors [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Norman Fixel Institute for Neurological Diseases	Gainesville	Florida	United States	32608

Sponsors and Collaborators

• University of Florida
• National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

• Principal Investigator: Sherrilene Classen, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04660500
• Other Study ID Numbers: IRB202002321
• First Posted: Dec 9, 2020
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Florida: Parkinson Disease; In-vehicle information system; Advanced driver assistance system
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Mar 24, 2022