Benefits of a Virtual Reality Based Cognitive Intervention for Attention and Working Memory
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Lodz
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Working memory
Study Overview
Brief Summary
The main objective of the study is to investigate the effects of using a set of Virtual Reality (VR)-based Digital Therapeutics (DTx) apps to improve the cognitive abilities of healthy (high-functioning) seniors. For the purposes of the study, high-functioning seniors are defined as being over the age of 65 years, while maintaining their functional independence with regards to activities of daily living, including the ability to go on a long walk and the ability to interact with common modern technology (e.g. using a smartphone to send a message).
The study focuses on improving the quality of life of older healthy people by facilitating cognitive training through VR. Healthy people aged 65-85 will be eligible for the project. If the participants meet the inclusion criteria, they will be invited to participate in the study and be provided with detailed information about the research project. Based on sample size calculations, up to two hundred (200) older adults are intended to be included in the project. The participants will use specially designed VR systems and activities aimed at improving their cognitive abilities.
Detailed Description
The participants that meet inclusion criteria will be randomly assigned to the experimental group or the control group. The participants in the experimental group will receive a cognitive intervention focused on attention and working memory through virtual reality handsets. The intervention will be delivered at home and monitored by the research team via wifi. The participants will be required to perform the cognitive training at least 3 times a week for 12 weeks (36 training sessions). The participants in the control group will see high definition images through VR handsets without cognitive training.
The CNS-Vital Signs, a computerized neuropsychological battery, will be used to assess primary outcomes (Working Memory and Complex Attention), and will be administered to the participants before the intervention and after 36 training sessions. Differences in performance on primary and secondary outcomes will be analyzed with a Linear Mixed Model Analysis of Variance for longitudinal outcomes. Measures of anxiety and well-being will also be registered.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The participants will be randomly assigned to either the experimental or the control group, and will be blind to the group assignment.
The data gathered before and after the intervention will be sent to an external statistical analyst blinded to group assignment.
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy or in a stable medical condition
- •Undisturbed locomotion
- •Do not require care or help from others in their everyday functioning
- •Are able to go on long walks unassisted
- •Are able to use common modern technology unassisted (e.g. using a smartphone to send a message)
Exclusion Criteria
- •Presence of neuropsychiatric disorders, including mild cognitive impairment (MCI) - Montreal Cognitive Assessment (MoCA) score <26 points
- •Abuse or addiction to alcohol, drugs and tranquilizers
- •Blurred vision that cannot be corrected with lenses or glasses that fit under the VR headset
- •Auditory pathologies causing a significant decrease in hearing unaided
- •High sensitivity to motion sickness
- •Proneness to migraines
- •Subject epileptic
- •Subject vulnerable
- •Subject obese or frail, as assessed based on their Body Mass Index (BMI)
- •Subject considered by the study investigator to be an unsuitable candidate to participate in the study, due to other relevant reasons
Arms & Interventions
VR training
VR training for at least 10 minutes at least three days per week, resulting in a total of at least 36 sessions (at least ~12 hours of training in total) for each participant, spread across three months. Each session will focus on cognitive training.
Intervention: VR training (Device)
VR activity
VR activity for at least 10 minutes at least three days per week, resulting in a total of at least 36 sessions (at least ~12 hours of training in total) for each participant, spread across three months, with 360º images and videos but without the interactive cognitive training.
Intervention: VR activity (Device)
Outcomes
Primary Outcomes
Working memory
Time Frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Assessed with the "Working Memory" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 38, with higher scores indicating better performance. A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Attention
Time Frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Assessed with the "Complex Attention" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 76, with higher scores indicating better performance. A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Secondary Outcomes
- The quality of life and the level of perceived well-being(Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).)
- Severity of anxiety symptoms(Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).)
- Cognitive functioning(Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).)
- Standard grip strength measurement using a dynamometer(Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).)
- Health-related quality of life(Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).)
Investigators
Jakub Kazmierski
Assoc. Prof. MD, PhD
Medical University of Lodz