Clinical trial NCT06838494: Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment
Official title: Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Mild Cognitive Impairment (MCI)
Cognitive stimulation therapy
immersive reality
Eye-tracking
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: University of Reading
name: Johns Hopkins University
First posted: 2025-02-20
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: Hong Kong Montreal Cognitive Assessment (HK-MoCA)
timeFrame: From 1-week pre-intervention to 13 weeks post-intervention
measure: Digit Span Forward and Backward Tasks
timeFrame: From 1-week pre-intervention to 13 weeks post-intervention
measure: Verbal Fluency of Semantic Category
timeFrame: From 1-week pre-intervention to 13 weeks post-intervention
Secondary outcomes:
measure: Chinese Version of the Modified Barthel Index
timeFrame: From 1-week pre-intervention to 13 weeks post-intervention
measure: Hong Kong Lawton Instrumental Activities of Daily Living Scale
timeFrame: From 1-week pre-intervention to 13 weeks post-intervention
measure: Feasibility Outcomes and Users' Experience
timeFrame: Throughout the intervention period (from weeks 1-7 of intervention)
measure: Semi-Structured Interview for IVR-CST Group
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: Hong Kong Polytechnic University
name: Winsy WS Wong, PHD
role: PRINCIPAL_INVESTIGATOR
References: