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

NCT ID: NCT06838494

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2027-04-30

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. 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?

Conditions

Mild Cognitive Impairment (MCI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IVR-CST Group

Group Type: EXPERIMENTAL

IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)

Intervention Type: 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).

Conventional CST Group

Group Type: ACTIVE_COMPARATOR

Intervention Name: Conventional CST (Cognitive Stimulation Therapy)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Winsy WS Wong, PHD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Winsy WS Wong, PHD

Role: CONTACT

wszewong@polyu.edu.hk

852-34003117

Facility Contacts

Winsy Wong, PhD

Role: primary

winsyws.wong@polyu.edu.hk

852 34003117

References

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.

Reference Type: DERIVED

PMID: 40857307 (View on PubMed)

Other Identifiers

22231471

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSEARS20241010009

Identifier Type: -

Identifier Source: org_study_id