Clinical trial NCT04660500: Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Official title: Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
In-vehicle information system
Advanced driver assistance system
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2020-12-09
Enrollment: 112
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Total number of driving errors
timeFrame: 1 year up to study completion
measure: Type and number of driving errors
timeFrame: 1 year up to study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Norman Fixel Institute for Neurological Diseases
state: Florida
Study officials:
affiliation: University of Florida
name: Sherrilene Classen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.