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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04600726
Other study ID # VR_Clinical Trial
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2022

Study information

Verified date October 2020
Source The Hong Kong Polytechnic University
Contact Frank HY Lai, Phd
Phone 91448014
Email frank.hy.lai@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date December 31, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no interventioni

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Department of Neuroscience, Psychology and Behavior. The University of Leicester, School of Psychology, The University of Nottingham, The Alice Ho Miu Ning Nethersole Hospital

References & Publications (4)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Delayed matching-to-place (DMP) a prototypical working memory test implemented in a virtual reality environment of the VRWMT 20 mins
Primary The Montreal Cognitive Assessment - Hong Kong Version 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
Primary The Chinese Multiple Errands Test 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
Primary Biological biomarkers for older adults with NCDs and Healthy Control 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