Mild Cognitive Impairment (MCI)
Conditions
Keywords
Mild Cognitive Impairment (MCI), Cognitive stimulation therapy, immersive reality, Eye-tracking
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?
Interventions
BEHAVIORALIVR-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).
BEHAVIORALIntervention 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).
Sponsors
The University of Hong Kong
University of Reading
Johns Hopkins University
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hong Kong Montreal Cognitive Assessment (HK-MoCA) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Chinese Version of the Modified Barthel Index | 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. |
| Semi-Structured Interview for IVR-CST Group | 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. |
| Hong Kong Lawton Instrumental Activities of Daily Living Scale | 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. |
| Feasibility Outcomes and Users' Experience | 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). |
Countries
Hong Kong
Contacts
Primary ContactWinsy WS Wong, PHD
Outcome results
None listed