Investigating the Effect of Training With a Virtual Reality Driving Simulator

NCT04074655 | Completed

• 1 other identifier: B2019:073
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to investigate the use of a driving simulator in a virtual reality (VR) environment to improve the cognition state and spatial navigation of individuals with mild/moderate memory impairment. All volunteers will be assessed by the Montreal Cognitive Assessment (MoCA),Montgomery-Asberg Depression Scale (MADRS) and Morris Water orientation tests for baseline assessment after they sign the consent form and are enrolled into the study. Participants will also be scheduled for post-intervention assessments (MADRS, Morris Water Orientation and a simple questionnaire on how they evaluate the experiment). Participants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks. Participants' daily performance data are recorded and uploaded on the secure server of the Priciple Investigator (PI). Simulator Sickness Questionnaire (SSQ) test will also be run after the first session of the experiment and at the end of the training period.

Conditions

Spatial Navigation; Navigation, Spatial; Dementia

Keywords

Driving Simulator; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test)

  Spatial orientation virtual reality experiment equivalent to Morris water test as primary outcome measure. This test is one of the PI's team designs used in a previous study (B2016:073), which is the VR replica of the standard Morris Water test; and will be run at baseline and at the end of trial (post-intervention). In this test participants sit behind a computer monitor and they move within a virtual maze to reach a particular target. They will do this test using the laptop screen. The test has 5 trials, and participants' trajectory to reaching the target is recorded. The ratio between the total trajectories and the trajectories in the correct quadrant, quadrant of which the target is placed in, is reported as the error of participant trying to find the target.

  Baseline and Intervention (end of 2-week exercise)

Secondary Outcomes (3)

• MADRS assessment

  Baseline and Intervention (end of 2-week exercise)

• SSQ questionnaire

  First session of the exercise and Intervention (end of 2-week exercise)

• Satisfaction questionnaire

  Intervention (end of 2-week exercise)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks.

Device: Driving Simulator in a Virtual Reality Environment

Interventions

Driving Simulator in a Virtual Reality Environment DEVICE

Driving simulator in virtual reality environment is a game with the several level of difficulty and the goal of improving the cognition level of participants in general and their spatial cognition in particular. Moreover this game, will have a positive effect on its users' mood as well.

Intervention Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age: 50+ years
• Have a score of 7\< MoCA \< 25
• Except the MCI/Alzheimer's diagnosis, have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, Huntington disease, Amyotrophic Lateral Sclerosis (ALS), Multiple sclerosis (MS), and/or any other neurological disorder.
• Fluency in reading/understanding English
• Furthermore, in this study we do not need to label participants as healthy or demented; we only use the MoCA range between 7 to 25 to enroll participants. Many healthy adults do have some memory impairments and have a MoCA score less than 25 but still consider themselves healthy. Thus, we do not label anyone in this study as healthy or demented.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Lindenwood Manor

Winnipeg, Manitoba, R3P1N3, Canada

Location

Related Publications (1)

• Masoumzadeh S, Moussavi Z. Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. Neurosci Insights. 2020 Nov 3;15:2633105520967930. doi: 10.1177/2633105520967930. eCollection 2020.

  PMID: 35174332 DERIVED

MeSH Terms

Conditions

Spatial Navigation; Dementia

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study we do not need to label participants as healthy or demented; we only use the MoCA range between 7 to 25 to enroll participants. Many healthy adults do have some memory impairments and have a MoCA score less than 25 but still consider themselves healthy. Thus, we do not label anyone in this study as healthy or demented.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 30, 2019
• Study Start: September 10, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)