Virtual Reality Cognitive Training for Mild Cognitive Impairment

NCT06380894 | Completed

• 1 other identifier: 2020/2239
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Virtual Reality Cognitive Training

EXPERIMENTAL

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

Active Control Group

ACTIVE COMPARATOR

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

Interventions

Virtual Reality Cognitive Training DEVICE

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.

Virtual Reality Cognitive Training

Active Control BEHAVIORAL

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.

Active Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhong Jie Zaylea Kua, MPsychClin

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 24, 2024
• Study Start: January 27, 2021
• Primary Completion: September 30, 2022
• Study Completion: January 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)