Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

NCT ID: NCT04045483

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-07
• Study Completion Date: 2020-03-14

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality based cognitive training

Intervention Type: OTHER

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.

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inha University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seong Hye Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Site Status: RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Seong Hye Choi, MD, PhD

Role: CONTACT

seonghye@inha.ac.kr

82 32 890 3659

Hye Lan Na, RN

Role: CONTACT

nhyelan@hanmail.net

82 32 890 1119

Facility Contacts

Seong Hye Choi, MD, PhD

Role: primary

seonghye@inha.ac.kr

Hye Lan Na, RN

Role: backup

nhyelan@hanmail.net

Jee Hyang Jeong, MD, PhD

Role: primary

Other Identifiers

2019-04-029

Identifier Type: -

Identifier Source: org_study_id