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NCT Number: NCT06838494

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

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?

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Chinese Version of the Modified Barthel Index

    Time frame: From 1-week pre-intervention to 13 weeks post-intervention

    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.

  2. Hong Kong Lawton Instrumental Activities of Daily Living Scale

    Time frame: From 1-week pre-intervention to 13 weeks post-intervention

    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.

  3. Feasibility Outcomes and Users' Experience

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

    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).

  4. Semi-Structured Interview for IVR-CST Group

    Time frame: Immediately post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Winsy WS Wong, PHD

CONTACT

[email protected]

852-34003117

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Johns Hopkins University
  • The University of Hong Kong
  • University of Reading

Registry information

Official study title

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

Acronym: VR-CST-MCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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