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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
older adults with known mild NCD
Older adults with known mild neuro-cognitive disorders
Other: no intervention
no interventioni
older adults with non-communicable diseases
older adults with non-communicable diseases such as diabetics, hypertension and chronic obstructive airway diseases
Other: no intervention
no interventioni
Older adults with healthy condition
Older adults who are free from neuro-cognitive disorders and non-communicable diseases
Other: no intervention
no interventioni

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Neuroscience, Psychology and Behavior. The University of Leicester
School of Psychology, The University of Nottingham
The Alice Ho Miu Ning Nethersole Hospital

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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