Parkinson DiseaseNCT03195608
Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
A study testing Lane change assistance system in people with Parkinson Disease and Driving Impaired, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease, Driving Impaired
- What is being tested?
- Lane change assistance system
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease, Driving Impaired
- Being tested
- Lane change assistance system, Active Control
- Keywords
- In-vehicle technologies, Parkinson's disease, Driving performance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lane change assistance systemDevice
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 ControlBehavioural
Also called Simulator practice
Participants will practice their driving on a driving simulator with feedback form a trained interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Device: Lane change assistance system |
| Control | Active comparator | 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)
Refers to the lateral position of the vehicle in the lane.
Measured: Baseline, 4 weeks, and 6 weeks
Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (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
Measured: Baseline, 4 weeks, and 6 weeks
Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)
Refers to the proper use of turning signals during lane changes
Measured: Baseline, 4 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start15 Apr 2019
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Alvarez Jaramillo, Western University, Canada
- Investigators
- Liliana Alvarez, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195608
- Sponsor's protocol ID
- 109272
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2017
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03195608
- Acronym / sponsor ID
- 109272
- Conditions
- Parkinson Disease, Driving Impaired
- Keywords
- In-vehicle technologies, Parkinson's disease, Driving performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Lane change assistance systemParticipants 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). |
| Control | Active comparator | Behavioral: Active ControlParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lane change assistance systemThis 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. | Device | Intervention |
| Active ControlAlso: Simulator practiceParticipants will practice their driving on a driving simulator with feedback form a trained interventionist. | Behavioural | Control |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Non-small Cell Lung Cancer (NSCLC)
RecruitingObservational study
Parkinson's Disease in Type 1 Gaucher Disease
Parkinson Disease (PD), Type 1 Gaucher Disease
RecruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
PARKINSON DISEASE (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liliana Alvarez, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lane change assistance system in people with Parkinson Disease and Driving Impaired, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.