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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06380894
Other study ID # 2020/2239
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date January 31, 2023

Study information

Verified date April 2024
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 31, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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