Mild Cognitive Impairment (MCI)VR-CST-MCINCT06838494
Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment
A study testing IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) and Intervention Name: Conventional CST (Cognitive Stimulation Therapy) in people with Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) and Intervention Name: Conventional CST (Cognitive Stimulation Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jul 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong
Winsy Wong, PhD, 852 34003117, winsyws.wong@polyu.edu.hk
About this study
Official title: 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:
- Is IVR-CST a feasible treatment for elderly with MCI?
- Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?
- Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?
- Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy), Intervention Name: Conventional CST (Cognitive Stimulation Therapy)
- Keywords
- Mild Cognitive Impairment (MCI), Cognitive stimulation therapy, immersive reality, Eye-tracking
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)Behavioural
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 Name: Conventional CST (Cognitive Stimulation Therapy)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| IVR-CST Group | Experimental | Not described Receives: Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) |
| Conventional CST Group | Active comparator | Not described Receives: Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: From 1-week pre-intervention to 13 weeks post-intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start3 Jul 2025 (estimated)
- Primary completion2 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, University of Reading, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Winsy WS Wong, PHD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838494
- Sponsor's protocol ID
- HSEARS20241010009
- Other IDs
- 22231471
- Acronym
- VR-CST-MCI
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
Publications
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.
PubMed 40857307
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06838494
- Acronym / sponsor ID
- VR-CST-MCI / HSEARS20241010009
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Mild Cognitive Impairment (MCI), Cognitive stimulation therapy, immersive reality, Eye-tracking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, University of Reading, Johns Hopkins University
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is IVR-CST a feasible treatment for elderly with MCI?
- Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI?
- Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI?
- Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | IVR-CST Group |
| 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). | Behavioural | Conventional CST Group |
Primary outcome
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Time frame: From 1-week pre-intervention to 13 weeks post-intervention
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.
Digit Span Forward and Backward Tasks
Time frame: From 1-week pre-intervention to 13 weeks post-intervention
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.
Verbal Fluency of Semantic Category
Time frame: From 1-week pre-intervention to 13 weeks post-intervention
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).
4 secondary outcomes
Chinese Version of the Modified Barthel Index
Time frame: From 1-week pre-intervention to 13 weeks post-intervention
Hong Kong Lawton Instrumental Activities of Daily Living Scale
Time frame: From 1-week pre-intervention to 13 weeks post-intervention
Feasibility Outcomes and Users' Experience
Time frame: Throughout the intervention period (from weeks 1-7 of intervention)
Semi-Structured Interview for IVR-CST Group
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40857307Wong 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.
- Individual participant dataSharing planned: Yes. The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winsy WS Wong, PHD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy) and Intervention Name: Conventional CST (Cognitive Stimulation Therapy) in people with Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winsy WS Wong, PHD (852-34003117, wszewong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hong Kong Montreal Cognitive Assessment (HK-MoCA) (time frame: From 1-week pre-intervention to 13 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.