Virtual Reality Cognitive Training for Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Virtual Reality Cognitive Training; Behavioral: Active Control

• Registration Number: NCT06380894
• Lead Sponsor: Changi General Hospital

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.

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 Timeline

• Study Start: 2021-01-27
• Primary Completion: 2022-09-30
• Study Completion: 2023-01-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Cognitive Training	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.
Active Control Group	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11	Baseline and 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.
Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11	Baseline and 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.
Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11	Baseline and 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.
Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11	Baseline and 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.
Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11	Baseline and 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.

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore