Clinical trial NCT04074655: Investigating the Effect of Training With a Virtual Reality Driving Simulator
Official title: Investigating the Effect of Training With a Virtual Reality Driving Simulator on Orientation Skills in Individuals With Some Memory Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spatial Navigation
Navigation, Spatial
Dementia
Keywords: Driving Simulator
Virtual Reality
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: After obtaining their consent and enrolling into the study, participants of the study will commit themselves to use the driving simulator daily (5 days/week), and 15-20 minutes/day for a period of 2 consecutive weeks. The location for these simulation sessions will be one of the Family rooms of the Lindenwood Retirement Community. During the experiment, the research assistant (RA) of the study will be present and monitor participants for any plausible simulator sickness. In case if a participant presents any simulator sickness symptom, the experiment will be stopped and the RA will remain with the participant until s/he feels alright to go back to his/her room or with a caregiver. The RA and PI may withdraw the participant from the study if it is for their benefit.

Participants' performance data and the duration of which they practice are all being recorded and uploaded on the secure server of the PI. After the end of the 2-week exercise program, participants will be assessed again by Morris Water orientation test, SSQ, and MADRS; SSQ test will also be run after the first session of the experiment.

Furthermore, their feedback about using the driving simulator will be collected through a

Eligibility criteria: Inclusion criteria:

We will recruit up to 30 volunteers with mild/moderate memory impairment. Inclusion/Exclusion Criteria

* 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.

Primary outcomes:
measure: The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test)
timeFrame: Baseline and Intervention (end of 2-week exercise)
Secondary outcomes:
measure: MADRS assessment
timeFrame: Baseline and Intervention (end of 2-week exercise)
measure: SSQ questionnaire
timeFrame: First session of the exercise and Intervention (end of 2-week exercise)
measure: Satisfaction questionnaire
timeFrame: Intervention (end of 2-week exercise)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Lindenwood Manor
state: Manitoba
Study officials:
References:
citation: 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.