Virtual Reality Cognitive Training for Mild Cognitive Impairment

Virtual Reality Cognitive Training for Mild Cognitive Impairment - A Pilot Feasibility Study

This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Virtual Reality Cognitive Training; Behavioral: Active Control

Detailed Description

This study employed a pilot feasibility parallel design approach. Participants were randomly assigned to either the VRCT intervention group or the active control group. The outcome assessor was blinded. Participants were recruited from outpatient clinics in Changi General Hospital, Singapore. They were referred by treating geriatricians and psycho-geriatricians.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 65-85
• diagnosis of MCI by a clinician in accordance to Petersen's criteria
• MMSE ≥ 23
• ability to see and hear
• ability to read and write in either English or Mandarin

Exclusion Criteria:

• diagnosed with a primary other neurocognitive disorder
• diagnosed with major psychiatric illness such as major depressive disorder or anxiety disorder, severe visual or auditory impairment
• diagnosed with serious medical illnesses including acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease or severe renal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Cognitive Training; The program consisted of two components: (1) psychoeducation on cognitive functioning and ways to maintain cognitive health, (2) VR multi-domain cognitive training tasks that target cognitive domains of attention, memory, and executive functioning.	Device: Virtual Reality Cognitive Training; Participants who were assigned to the VRCT intervention group underwent 60 minutes of weekly VRCT sessions over a 10-week intervention period. The program consisted of two components: (1) psychoeducation on cognitive functioning and ways to maintain cognitive health, (2) VR multi-domain cognitive training tasks that target cognitive domains of attention, memory, and executive functioning. The VR experiences were administered through a head-mounted Oculus Go Screen V7. The VR system runs on a software developed by Dancing Mind Pte Ltd. The software specifications and service provided by Dancing Mind Pte Ltd include: MindGym System Functions: System Setup (Processor Setup, Password Changing etc) and Data Centre (Memory Care Therapy Data Analytics Report Querying and Printing Functions). The MindGym cognitive training content was developed based on the Singaporean culture, with visual stimuli reflecting familiar local environments.
Active Comparator: Active Control Group; Participants who were assigned to the active control group were provided treatment-as-usual, which included: (1) psychoeducation on MCI, cognitive functioning, and compensatory strategies, and (2) brain training cognitive stimulation booklet which consisted of weekly homework activities focusing on attention, memory, and executive functioning. Control participants were reviewed for 3 sessions monthly to follow up on their progress on the cognitive stimulation activity booklet.	Behavioral: Active Control; Participants who were assigned to the active control group were provided treatment-as-usual, which included: (1) psychoeducation on MCI, cognitive functioning, and compensatory strategies, and (2) brain training cognitive stimulation booklet which consisted of weekly homework activities focusing on attention, memory, and executive functioning. Control participants were reviewed for 3 sessions monthly to follow up on their progress on the cognitive stimulation activity booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11	The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtests of List Learning, List Recall and List Recognition measures verbal memory while Picture Copy and Picture Recall measures visual memory. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of each subtests are compared.	Baseline and Week 11
Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11	The RBANS is a comprehensive neuropsychological battery that has been validated with local norms in Singapore. Its subtest of Digit Span measures attention. It is administered by trained clinical research coordinators and scored by neuropsychologists. Raw scores of the Digit Span subtest is compared.	Baseline and Week 11
Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11	The Colour Trails Test 1 requires the respondent to connect circles in an ascending numbered sequence. Time taken to complete each part of the CTT is recorded in seconds.	Baseline and Week 11
Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11	The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18.	Baseline and Week 11
Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11	The FAB is a short screening tests used to evaluate executive function. Its components consist of S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test. The sum of the sub-scores from each of the six components are added up to generate total score out of 18.	Baseline and Week 11

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Investigators: Principal Investigator: Zhong Jie Zaylea Kua, MPsychClin, Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2020/2239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No