Back to results

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

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Virtual reality based cognitive training

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring virtual reality

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inha University HospitalRecruiting
Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR based cognitive training

Usual care

Arm Description

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.

Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04045483

First Posted

July 26, 2019

Last Updated

August 2, 2019

Sponsor

Inha University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04045483

Brief Title

Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

Acronym

VRMCI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 7, 2019 (Actual)

Primary Completion Date

February 28, 2020 (Anticipated)

Study Completion Date

March 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

virtual reality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study is a single-blind, randomized, controlled, two-period crossover trial.

Masking

Outcomes Assessor

Masking Description

Raters of efficacy measures are blind to the group of a participant.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR based cognitive training

Arm Type

Experimental

Arm Description

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.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care.

Intervention Type

Other

Intervention Name(s)

Virtual reality based cognitive training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Measurement of memory, visuospatial function, language, and executive function The range of score is from 0 to 100. The higher score means better cognition.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change of Mini-Mental State Examination from baseline at 6 weeks

Description

Evaluation of global cognition The range of score is from 0 to 30. The higher score means better cognition.

Time Frame

6 weeks

Title

Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks

Description

Evaluation of global cognition The range of score is from 0 to 18. The higher score means better cognition.

Time Frame

6 weeks

Title

Change of Quality of life-Alzheimer's disease from baseline at 6 weeks

Description

Evaluation of quality of life The range of score is from 0 to 52. The higher score means better quality of life.

Time Frame

6 weeks

Title

Change of Geriatric Depression Scale-15 items from baseline at 6 weeks

Description

Evaluation of mood The range of score is from 0 to 15. A higher score means more depression.

Time Frame

6 weeks

Title

Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks

Description

Evaluation of subjective memory The range of score is from 16 to 80. The higher score means more memory impairment.

Time Frame

6 weeks

Title

Change of Bayer Activities of Daily Living from baseline at 6 weeks

Description

Evaluation of activities of daily living The range of score is from 1 to 10. The higher score means worse ADL.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seong Hye Choi, MD, PhD

Phone

82 32 890 3659

seonghye@inha.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Hye Lan Na, RN

Phone

82 32 890 1119

nhyelan@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seong Hye Choi, MD, PhD

Organizational Affiliation

Inha University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seong Hye Choi, MD, PhD

seonghye@inha.ac.kr

First Name & Middle Initial & Last Name & Degree

Hye Lan Na, RN

nhyelan@hanmail.net

Facility Name

Ewha Womans University Mokdong Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jee Hyang Jeong, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jee Hyang Jeong, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We will decide it later.

Learn more about this trial

Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

We'll reach out to this number within 24 hrs