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NCT06838494 | NOT YET RECRUITING | Mild Cognitive Impairment (MCI)

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

The Hong Kong Polytechnic University

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?

Condition or disease

Mild Cognitive Impairment (MCI)

Intervention/treatment

IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)

Intervention Name: Conventional CST (Cognitive Stimulation Therapy)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 66 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study
Actual Study Start Date : 2025-07-03
Estimated Primary Completion Date : 2026-10-02
Estimated Study Completion Date : 2027-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment

Location Details

NCT06838494

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Locations

Not yet recruiting

Hong Kong,

The Hong Kong Polytechnic University

Hong Kong, Hong Kong,