Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment

NCT06838494 | Not Yet Recruiting

• 2 other identifiers: HSEARS2024101000922231471
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment (MCI); Cognitive stimulation therapy; immersive reality; Eye-tracking

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Chinese Version of the Modified Barthel Index

  From 1-week pre-intervention to 13 weeks post-intervention

• Hong Kong Lawton Instrumental Activities of Daily Living Scale

  From 1-week pre-intervention to 13 weeks post-intervention

• Feasibility Outcomes and Users' Experience

  Throughout the intervention period (from weeks 1-7 of intervention)

• Semi-Structured Interview for IVR-CST Group

  Immediately post-intervention

Study Arms (2)

IVR-CST Group

EXPERIMENTAL

Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)

Conventional CST Group

ACTIVE COMPARATOR

Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy)

Interventions

IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) BEHAVIORAL

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).

IVR-CST Group

Intervention Name: Conventional CST (Cognitive Stimulation Therapy) BEHAVIORAL

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).

Conventional CST Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elderly aged 60 years or above,
• 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,
• ability to speak and comprehend Cantonese,
• normal or corrected-to-normal binocular vision and hearing,
• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator
• University of Reading: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• Wong WWS, Wong GHY, Choy JCP, Pui Li DS, Lo YL. Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for elderly with mild cognitive impairment: A randomized controlled pilot study protocol. PLoS One. 2025 Aug 26;20(8):e0330686. doi: 10.1371/journal.pone.0330686. eCollection 2025.

  PMID: 40857307 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Winsy WS Wong, PHD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winsy WS Wong, PHD

CONTACT

852-34003117; wszewong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 20, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared starting from three months after manuscript publication.
• Access Criteria: The IPD and study protocol will be shared in an open-access data repository without restrictions.

Locations

HK (1)