Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment (VRMCI)

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

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

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Virtual reality based cognitive training

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seong Hye Choi, MD, PhD; Phone Number: 82 32 890 3659; Email: seonghye@inha.ac.kr
• Study Contact Backup: Name: Hye Lan Na, RN; Phone Number: 82 32 890 1119; Email: nhyelan@hanmail.net

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Recruiting
    • Inha University Hospital
    • Contact: Seong Hye Choi, MD, PhD; Email: seonghye@inha.ac.kr
    • Contact: Hye Lan Na, RN; Email: nhyelan@hanmail.net
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Ewha Womans University Mokdong Hospital
    • Contact: Jee Hyang Jeong, MD, PhD
    • Principal Investigator: Jee Hyang Jeong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR 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.	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.
No Intervention: Usual care; Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Investigators: Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2019
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): March 14, 2020

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2019-04-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will decide it later.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No