Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment (VR-CST-MCI)

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy); Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06838494

HSEARS20241010009

22231471 (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Enrollment: 66 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

IVR-CST Group

Experimental group

Treatment:

Behavioral: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)

Conventional CST Group

Active Comparator group

Treatment:

Behavioral: Intervention Name: Conventional CST (Cognitive Stimulation Therapy)