Clinical trial NCT05369897: VR for Improving Attention and Working Memory
Official title: Benefits of a Virtual Reality Based Cognitive Intervention for Attention and Working Memory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
name: Senopi AG
First posted: 2022-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Working memory
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
measure: Attention
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Secondary outcomes:
measure: Cognitive functioning
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
measure: Standard grip strength measurement using a dynamometer
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
measure: The quality of life and the level of perceived well-being
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
measure: Severity of anxiety symptoms
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
measure: Health-related quality of life
timeFrame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Study officials:
affiliation: Medical University of Lodz, Poland
name: Jakub M Kaźmierski, PhD
role: PRINCIPAL_INVESTIGATOR
References: