Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment (VR-CST-MCI)

Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study

The proposed study aims to investigate the potential of IVR-CST in improving cognition of people with MCI, and as well the association of eye movement during therapy and treatment outcomes of IVR-CST. Four research questions have been proposed and listed as follows:

1. Is IVR-CST a feasible treatment for elderly with MCI?
2. Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?
3. Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?
4. Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy); Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy)

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winsy WS Wong, PhD; Phone Number: 852-34003117; Email: wszewong@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University
    • Contact: Winsy Wong, PhD; Phone Number: 852 34003117; Email: winsyws.wong@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. elderly aged 60 years or above,
2. a diagnosis of MCI made by a psychiatrist, or a score of 16-21 out of 30 in the Hong Kong Brief Cognitive Test (HKBC, 31), with upper and lower cutoff scores for MCI as suggested by the test. HKBC has been validated in Hong Kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with MCI and healthy individuals,
3. ability to speak and comprehend Cantonese,
4. normal or corrected-to-normal binocular vision and hearing,
5. absence of physical illness/disability to prevent them from IVR-CST participation, 6, compatible with IVR exposure in the 10-minute IVR trial without major signs of cybersickness, based on the symptoms given in the Simulator Sickness Questionnaire

Exclusion Criteria:

1. concurrent participation in other clinical therapy trials,
2. incompatibility with IVR exposure such as complaints of nausea, headache, or other severe discomforts during trial use,
3. a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, Parkinson's disease
4. hearing/visual/upper limb impairments that hinder CST/IVR-CST participation,
5. prior CST treatment,
6. Use of medication for MCI/dementia, e.g., aducanumab

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVR-CST Group	Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy); IVR-CST involves 14 sessions of cognitive stimulation therapy conducted twice a week in a virtual reality environment. Each session lasts approximately 45 minutes and utilizes head-mounted displays (HMDs) to immerse participants in engaging, themed activities. The therapy aims to enhance cognitive function and social interaction through interactive and stimulating virtual experiences tailored for individuals with mild cognitive impairment (MCI).
Active Comparator: Conventional CST Group	Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy); Conventional CST consists of 14 sessions of cognitive stimulation therapy conducted twice a week, each lasting about 45 minutes. In this arm, participants engage in group activities using physical materials, such as photos, pictures, and real objects, rather than virtual reality. The therapy focuses on providing cognitive stimulation through discussions and activities designed to improve cognitive function and social engagement among individuals with mild cognitive impairment (MCI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hong Kong Montreal Cognitive Assessment (HK-MoCA)	Hong Kong Montreal Cognitive Assessment (HK-MoCA) Measurement of global cognition in participants, covering various cognitive domains such as visuo-spatial skills, executive functions, attention, memory, language, and orientation. The total score ranges from 1-30, with higher score indicating better performance.	From 1-week pre-intervention to 13 weeks post-intervention
Digit Span Forward and Backward Tasks	Assessment of working memory capacity, predicting progression from MCI to dementia. The test will start from 1 digit with increasing number of digit to increase level of difficulty.	From 1-week pre-intervention to 13 weeks post-intervention
Verbal Fluency of Semantic Category	Evaluation of semantic integrity, cognitive flexibility, and executive function by measuring the number of items correctly produced in one minute across different semantic categories (animals, fruits, transportation).	From 1-week pre-intervention to 13 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese Version of the Modified Barthel Index	Assessment of the level of independence in activities of daily living, including grooming, feeding, mobility, toileting, and more. The test score ranges from 1-100 with higher scores indicating better performance.	From 1-week pre-intervention to 13 weeks post-intervention
Hong Kong Lawton Instrumental Activities of Daily Living Scale	Evaluation of independence in performing community-living skills, such as cooking, household management, and shopping. The test score ranged from 0-18 and a higher score indicates better performance.	From 1-week pre-intervention to 13 weeks post-intervention
Feasibility Outcomes and Users' Experience	Objective measures of feasibility, including the number of adverse events and technical issues during the intervention, as well as adherence to the intervention protocol (actual duration and number of sessions conducted vs. scheduled).	Throughout the intervention period (from weeks 1-7 of intervention)
Semi-Structured Interview for IVR-CST Group	Post-therapy interview assessing comfort levels, presence of adverse effects (e.g., cybersickness), and the impact of therapy on daily functions. Conducted by a trained research assistant in a quiet clinical room, with the session audio-taped.	Immediately post-intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Johns Hopkins University; The University of Hong Kong; University of Reading
• Investigators: Principal Investigator: Winsy WS Wong, PhD, Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): July 3, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment (MCI); Eye-tracking; Cognitive stimulation therapy; immersive reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: HSEARS20241010009; 22231471 (Other Grant/Funding Number: Health and Medical Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
• IPD Sharing Time Frame: Data will be shared starting from three months after manuscript publication.
• IPD Sharing Access Criteria: The IPD and study protocol will be shared in an open-access data repository without restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No