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

Inha University Hospital

Status: Unknown

Conditions: Mild Cognitive Impairment

Treatments: Other: Virtual reality based cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT04045483

2019-04-029

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

VR based cognitive training

Experimental group

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.

Treatment:

Other: Virtual reality based cognitive training

Usual care

No Intervention group

Description:

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