Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— VRMCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045483
• Other study ID #: 2019-04-029
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: March 14, 2020

Study information

• Verified date: August 2019
• Source: Inha University Hospital
• Contact: Seong Hye Choi, MD, PhD
• Phone: 82 32 890 3659
• Email: seonghye[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 14, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Virtual reality based cognitive training
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.

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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