VR for Improving Attention and Working Memory

NCT05369897 | Unknown

• 1 other identifier: RNN/222/21/KE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Working memory

  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.

  Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).

• Attention

  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.

  Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).

Secondary Outcomes (5)

• 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).

• 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).

• Health-related quality of life

  Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).

Study Arms (2)

VR training

EXPERIMENTAL

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.

Device: VR training

VR activity

SHAM COMPARATOR

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.

Device: VR activity

Interventions

VR training DEVICE

The intervention group will receive cognitive training through VR headsets three times a week for 12 weeks. The intervention will be delivered in a virtual setting using images and music. The participants will be allowed to select the type of music and virtual environment during the intervention. The intervention will include four modules targeting attention and working memory through immersive VR.

VR training

VR activity DEVICE

High-quality 360º images and videos from natural environments, such as a relaxing mountain environment. The participants in the control group will not receive cognitive training.

VR activity

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead
• National Center for Research and Development, Poland: collaborator
• Senopi AG: collaborator

Study Sites (1)

Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Lodz, 92-213, Poland

RECRUITING

Related Publications (2)

• Szczepocka E, Mokros L, Kazmierski J, Nowakowska K, Lucka A, Antoszczyk A, Oltra-Cucarella J, Werzowa W, Hellevik MM, Skouras S, Bagger K. The Effectiveness of Virtual Reality-Based Training on Cognitive, Social, and Physical Functioning in High-Functioning Older Adults (CoSoPhy FX): 2-Arm, Parallel-Group Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 5;13:e53261. doi: 10.2196/53261.

  PMID: 38837194 DERIVED

• Szczepocka E, Mokros L, Kazmierski J, Nowakowska K, Lucka A, Antoszczyk A, Oltra-Cucarella J, Werzowa W, Hellevik M, Skouras S, Bagger K. Virtual reality-based training may improve visual memory and some aspects of sustained attention among healthy older adults - preliminary results of a randomized controlled study. BMC Psychiatry. 2024 May 8;24(1):347. doi: 10.1186/s12888-024-05811-2.

  PMID: 38720251 DERIVED

Study Officials

• Jakub M Kaźmierski, PhD

  Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub M Kaźmierski, PhD

CONTACT

426757232; jakub.kazmierski@umed.lodz.pl

Ewa Ł Szczepocka, PhD

CONTACT

426757346; ewa.szczepocka@umed.lodz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD, PhD

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 11, 2022
• Study Start: April 30, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after the first publication. There is no time restriction for sharing the data.
• Access Criteria: Through formal application. Applicants will be asked to sign a data access agreement to ensure a commitment to using the data only for research purposes and to securing the data with appropriate procedures.

Locations

PL (1)