Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

NCT04045483 | Unknown DMC

• 1 other identifier: 2019-04-029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Mild Cognitive Impairment

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (6)

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  6 weeks

Study Arms (2)

VR based cognitive training

EXPERIMENTAL

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.

Other: Virtual reality based cognitive training

Usual care

NO INTERVENTION

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

Interventions

Virtual reality based cognitive training 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.

VR based cognitive training

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (2)

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Seong Hye Choi, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Hye Choi, MD, PhD

CONTACT

82 32 890 3659; seonghye@inha.ac.kr

Hye Lan Na, RN

CONTACT

82 32 890 1119; nhyelan@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters of efficacy measures are blind to the group of a participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 5, 2019
• Study Start: June 7, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 14, 2020
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)