Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Other: Virtual reality based cognitive training

• Registration Number: NCT04045483
• Lead Sponsor: Inha University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-07
• Study First Submitted: 2019-07-26
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-05
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged 50-85
2. A memory complaint by a participant or caregiver
3. 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
4. MMSE score better than1.5 SD below age and education-adjusted normative means
5. Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1
6. Preserved activities of daily living (ADL), as defined by Korean Instrumental Activities of Daily Living < 0.4
7. Not demented
8. Hachinski Ischemic Score ≤ 4
9. Can read and write Korean
10. brain MRI or CT showing no other diseases capable of producing cognitive impairment
11. Having a reliable informant who could provide investigators with the requested information.
12. Provide written informed consent

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Exclusion Criteria

1. Participated in another clinical trial within the past 4 weeks
2. 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
3. A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology
4. A primary other neurodegenerative disorder
5. Major psychiatric illness such as major depressive disorders
6. Drug or alcohol addiction during the past 10 years
7. Severe loss of vision, hearing, or communicative disability
8. Malignancy within 5 years
9. Any conditions preventing cooperation as judged by the study physician

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VR based cognitive training	Virtual reality based cognitive training	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.

Primary Outcome Measures

Name	Time	Method
Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of