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

Inha University Hospital2 sites in 1 country30 target enrollmentJune 7, 2019

ConditionsMild Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Cognitive Impairment
Sponsor: Inha University Hospital
Enrollment: 30
Locations: 2
Primary Endpoint: Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 7, 2019

End Date

March 14, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Inha University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

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

Outcomes

Primary Outcomes

Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks

Time Frame: 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 Outcomes

Change of Mini-Mental State Examination from baseline at 6 weeks(6 weeks)
Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks(6 weeks)
Change of Quality of life-Alzheimer's disease from baseline at 6 weeks(6 weeks)
Change of Geriatric Depression Scale-15 items from baseline at 6 weeks(6 weeks)
Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks(6 weeks)
Change of Bayer Activities of Daily Living from baseline at 6 weeks(6 weeks)