- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600726
Application of VR-based Working Memory Screening Test (VR)
October 19, 2020 updated by: Dr Frank LAI, The Hong Kong Polytechnic University
Application of VR-based Working Memory Screening Test to Facilitate Early Detection of Dementia
We propose to validate an interactive, immersive spatial memory test from the laboratory test.
This VR-based working memory test (VRWMT) is a first-person, self-pacing game embedded within a virtual reality environment, the program is easily implemented with minimal instructions and no supervision that can be community-users friendly.
It is specifically designed to assess rapid spatial working memory - a common deficit in all NCD subtypes.
Its ability to detect pathological models of dementia, age-related deterioration, and hippocampal dysfunction are well established in literature
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The proposed research aims to study the ability of VRWMT to discriminate between older adults with known mild NCD, healthy age-matched older adults and participants with non-communicable diseases and to predict their deterioration in cognitive function over a period of 12 months.
Moreover, this study is to characterize and evaluate any concurrent validity between emergence of deterioration in the VRWMT and clinical tools of functional performance in older adults.
Additionally, the potential of inflammatory and metabolic dysregulation biomarkers to increase our ability to detect early NCD risk over and above the predictive validity of the VRWMT.
The study findings will bring both social and clinical significance to ageing and NCD research.
The combination of behavioural and biomarkers of pathological significance offers an innovative approach that potentially addresses the limitations intrinsic to either measure alone.
Study Type
Observational
Enrollment (Anticipated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Frank HY Lai, Phd
- Phone Number: 91448014
- Email: frank.hy.lai@polyu.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Older adults who are community dwelling
Description
Inclusion Criteria:
- the ability to understand verbal and written Chinese instructions
- the ability and willingness to provide informed consent and sign the relevant document.
Exclusion Criteria:
- a history of substance abuse including alcohol, drugs, or any medication/substances indicative of chronic abuse;
- participants with major NCD.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
older adults with known mild NCD
Older adults with known mild neuro-cognitive disorders
|
no interventioni
|
|
older adults with non-communicable diseases
older adults with non-communicable diseases such as diabetics, hypertension and chronic obstructive airway diseases
|
no interventioni
|
|
Older adults with healthy condition
Older adults who are free from neuro-cognitive disorders and non-communicable diseases
|
no interventioni
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed matching-to-place (DMP)
Time Frame: 20 mins
|
a prototypical working memory test implemented in a virtual reality environment of the VRWMT
|
20 mins
|
|
The Montreal Cognitive Assessment - Hong Kong Version
Time Frame: 15 mins
|
The MoCA-HK is an examiner-rated cognitive screening test that evaluates visuospatial functions, naming, attention and working memory, language, abstraction, and orientation, commonly affected in NCD including Alzheimer's disease, stroke, and vascular dementia.
It is a validated tool for detecting cognitive impairment in Chinese Hong Kong population at early stages.
It is a common tool in practical practice that can be under 15 minutes.
MoCA scores range from 0 to 30.
Subjects with a score of above 21 will be classified as "healthy controls", while 21 or below will be included in the mild NCD group in the present study.
|
15 mins
|
|
The Chinese Multiple Errands Test
Time Frame: 20 mins
|
A functional performance measure of executive function that identifies abnormalities known for its ecological validity through assessment of real-world daily living activities.
The proposed study will evaluate the ability of working memory (as a component to executive function) from VRWMT to predict executive functions (globally) across the six scores obtained from the Chinese Multiple Errands Test
|
20 mins
|
|
Biological biomarkers for older adults with NCDs and Healthy Control
Time Frame: 5 mins
|
The panel of biomarkers covers five immune cytokines and two metabolic markers (including serum IL-1B,Interleukin 6, Interleukin 10, Interleukin 33, Tumor Necrosis Factor alpha, Leptin and Glycosylated haemoglobin A1c (HbA1c)
|
5 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Daugherty AM, Raz N. A virtual water maze revisited: Two-year changes in navigation performance and their neural correlates in healthy adults. Neuroimage. 2017 Feb 1;146:492-506. doi: 10.1016/j.neuroimage.2016.09.044. Epub 2016 Sep 19.
- Daugherty AM, Bender AR, Yuan P, Raz N. Changes in Search Path Complexity and Length During Learning of a Virtual Water Maze: Age Differences and Differential Associations with Hippocampal Subfield Volumes. Cereb Cortex. 2016 Jun;26(6):2391-401. doi: 10.1093/cercor/bhv061. Epub 2015 Apr 1.
- Folley BS, Astur R, Jagannathan K, Calhoun VD, Pearlson GD. Anomalous neural circuit function in schizophrenia during a virtual Morris water task. Neuroimage. 2010 Feb 15;49(4):3373-84. doi: 10.1016/j.neuroimage.2009.11.034. Epub 2009 Dec 4.
- Daugherty AM, Yuan P, Dahle CL, Bender AR, Yang Y, Raz N. Path Complexity in Virtual Water Maze Navigation: Differential Associations with Age, Sex, and Regional Brain Volume. Cereb Cortex. 2015 Sep;25(9):3122-31. doi: 10.1093/cercor/bhu107. Epub 2014 May 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2021
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 19, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR_Clinical Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.