Clinical trial NCT04045483: Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
Official title: A Randomized Controlled Crossover Trial to Assess Efficacy of Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: virtual reality
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a single-blind, randomized, controlled, two-period crossover trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change of Mini-Mental State Examination from baseline at 6 weeks
timeFrame: 6 weeks
measure: Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks
timeFrame: 6 weeks
measure: Change of Quality of life-Alzheimer's disease from baseline at 6 weeks
timeFrame: 6 weeks
measure: Change of Geriatric Depression Scale-15 items from baseline at 6 weeks
timeFrame: 6 weeks
measure: Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks
timeFrame: 6 weeks
measure: Change of Bayer Activities of Daily Living from baseline at 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Inha University Hospital
name: Seong Hye Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: