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Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03195608
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Liliana Alvarez Jaramillo, Western University, Canada

Brief Summary:
Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that increase the crash risk in this population. Current vehicle automation technologies are available, that although designed for the general public, may help drivers with PD stay on the roads longer and safer than currently possible. Using a driving simulator (a safe and cost-effective alternative with no impact on licensing for participants), this study will investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology (i.e., a simulated lane change assistance system) to address critical driving errors in individuals with mild to moderate Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Driving Impaired Device: Lane change assistance system Behavioral: Active Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will be masked regarding the pre or post-test status of the assessment.
Primary Purpose: Device Feasibility
Official Title: Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants will complete a standardized battery of paper and pencil and computer tests. Following these tests, participants will complete a baseline simulator driving assessment without any form of assistive technology. We will employ a CDS-200 driving simulator (DriveSafety Inc., Salt Lake City, UT). A trained blinded evaluator will observe the recorded drive and score the drive. After the baseline assessment, participants will engage in 3 intervention sessions (lasting 30 minutes each). During these sessions, the lane change assistance system will be introduced and participants will be taught how to use it. After the 3 sessions, participants will participate in a post-test, similar to the baseline assessment but with a different route within the simulated world. They will drive this new route with the assistive technology. One to two weeks after the post-test, participants will be invited to participate in a follow-up assessment (battery of tests and simulator assessment).
Device: Lane change assistance system
This study will investigate the feasibility and preliminary efficacy of a 6-session lane change ADAS-intervention on the simulated driving performance of individuals with mild to moderate PD. We anticipate that the use of lane change assist technology will decrease the number of driving errors in individuals with PD. As this is a feasibility study, we will evaluate: -recruitment capability and sample characteristics - data collection methods, procedures, and outcome measures - acceptability and suitability of the lane change assist technology intervention - preliminary efficacy The outcomes of this study will inform the design of a larger study, should such large-scale study be warranted.

Active Comparator: Control
Participants will complete a standardized battery of paper and pencil and computer tests. Following these tests, participants will complete a baseline simulator driving assessment without any form of assistive technology. We will employ a CDS-200 driving simulator (DriveSafety Inc., Salt Lake City, UT). A trained blinded evaluator will observe the recorded drive and score the drive. After the baseline assessment, participants will engage in 3 intervention sessions (lasting 30 minutes each). During these sessions, participants will drive the scenario and receive feedback from a trained evaluator regarding their live performance. No lane change assistance system will be utilized. After the 3 sessions, participants will participate in a post-test, similar to the baseline assessment but with a different route within the simulated world.
Behavioral: Active Control
Participants will practice their driving on a driving simulator with feedback form a trained interventionist.
Other Name: Simulator practice




Primary Outcome Measures :
  1. Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks) [ Time Frame: Baseline, 4 weeks, and 6 weeks ]
    Refers to the lateral position of the vehicle in the lane.

  2. Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks) [ Time Frame: Baseline, 4 weeks, and 6 weeks ]
    Visual scanning is defined as eye movement and turning of the neck and head (e.g. glances, look sideways at an intersection, look at mirrors) to detect oncoming objects

  3. Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks) [ Time Frame: Baseline, 4 weeks, and 6 weeks ]
    Refers to the proper use of turning signals during lane changes



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be 21 years of age or older (as a feasibility study, this study will provide the opportunity to participate to those diagnosed with early onset PD)
  • Have been diagnosed with Parkinson's disease by a neurologist or movement disorder specialist
  • Currently hold a valid G driver's license
  • Meet provincial visual acuity (20/50 binocular) and visual field (120 continuous along the horizontal meridian with both eyes examined together) requirements for driving
  • Be proficient in English reading and speaking (self-reported).

Exclusion Criteria:

  • Have any other neurological or psychiatric conditions that would interfere with full participation in the study
  • Be taking psychotropic medication(s) that affect their mental and/or physical functioning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195608


Contacts
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Contact: Liliana Alvarez, PhD 5196612111 ext 88957 lalvare2@uwo.ca

Locations
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Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada, N6G1H1
Contact: Robert Colonna, BSc    5196612111 ext 88964    rcolonna@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Liliana Alvarez, PhD University of Western Ontario, Canada

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Responsible Party: Liliana Alvarez Jaramillo, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03195608     History of Changes
Other Study ID Numbers: 109272
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liliana Alvarez Jaramillo, Western University, Canada:
In-vehicle technologies
Parkinson's disease
Driving performance
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases