Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

Study Overview
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Brief Summary
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This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.

Detailed Description
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This study is a single-blind, randomized, controlled, two-period crossover trial. The intervention is done twice a week for 6 weeks. There are two arms. During the first period, participants were randomized to receive either VR-based cognitive training or usual care. After a 2-week washout period, the groups were crossed over to receive the alternative treatment for 6 weeks.

Official Title
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A Randomized Controlled Crossover Trial to Assess Efficacy of Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: Virtual reality based cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 50-85 A memory complaint by a participant or caregiver Objective memory decline as defined by a delayed recall score of verbal learning test or logical memory worse than 1.0 standard deviations (SD) below age and education-adjusted normative mean MMSE score better than1.5 SD below age and education-adjusted normative means Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1 Preserved activities of daily living (ADL), as defined by Korean Instrumental Activities of Daily Living < 0.4 Not demented Hachinski Ischemic Score ≤ 4 Can read and write Korean brain MRI or CT showing no other diseases capable of producing cognitive impairment Having a reliable informant who could provide investigators with the requested information. Provide written informed consent Exclusion Criteria: Participated in another clinical trial within the past 4 weeks Other serious or unstable medical disease such as acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease, or severe renal disease A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology A primary other neurodegenerative disorder Major psychiatric illness such as major depressive disorders Drug or alcohol addiction during the past 10 years Severe loss of vision, hearing, or communicative disability Malignancy within 5 years Any conditions preventing cooperation as judged by the study physician

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a single-blind, randomized, controlled, two-period crossover trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR based cognitive training<br>Participants perform the VR based cognitive training under the supervision of a research nurse or psychologist for 30 min per session, twice per week, over the 6-week intervention period. | Other: Virtual reality based cognitive training<br>* The VR-based cognitive training consists of a three-dimensional simulation of home, a mart, bus stop, and street. It provides an integrative cognitive training experience where participants are required to accomplish some common ADL's in three frequently visited places: home, a supermarket, and bus stop.<br>|
| No Intervention: Usual care<br>Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks | Measurement of memory, visuospatial function, language, and executive function The range of score is from 0 to 100. The higher score means better cognition. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mini-Mental State Examination from baseline at 6 weeks | Evaluation of global cognition The range of score is from 0 to 30. The higher score means better cognition. | 6 weeks | 
| Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks | Evaluation of global cognition The range of score is from 0 to 18. The higher score means better cognition. | 6 weeks | 
| Change of Quality of life-Alzheimer's disease from baseline at 6 weeks | Evaluation of quality of life The range of score is from 0 to 52. The higher score means better quality of life. | 6 weeks | 
| Change of Geriatric Depression Scale-15 items from baseline at 6 weeks | Evaluation of mood The range of score is from 0 to 15. A higher score means more depression. | 6 weeks | 
| Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks | Evaluation of subjective memory The range of score is from 16 to 80. The higher score means more memory impairment. | 6 weeks | 
| Change of Bayer Activities of Daily Living from baseline at 6 weeks | Evaluation of activities of daily living The range of score is from 1 to 10. The higher score means worse ADL. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality