Status:
UNKNOWN
Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
Lead Sponsor:
Inha University Hospital
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
NA
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04045483
Start Date
June 7 2019
End Date
March 14 2020
Last Update
August 5 2019
Active Locations (2)
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1
Inha University Hospital
Incheon, South Korea, 22332
2
Ewha Womans University Mokdong Hospital
Seoul, South Korea