None listed
Conditions
Interventions
Medical Device : 1. Study Population: The target population consists of individuals undergoing screening for mild cognitive impairment using a virtual reality cognitive assessment program.
2. Key Inte
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Mild Cognitive Impairment (MCI) Group (individuals meeting all of the following criteria): 1) Participants aged 60 or older who have consented to research participation 2) Individuals who have a sufficient understanding of and provide consent for the research purpose and process 3) Those who subjectively report cognitive decline or are acknowledged by family members for cognitive impairment 4) Individuals with overall preserved cognitive function and, as judged by a physician, exhibit no problems in daily life 5) Participants with a Clinical Dementia Rating (CDR) score of 0.5 6) Individuals with a CDR Sum of Boxes (CDR-SB) score of 4 or lower, indicating no dementia-related functional issues in daily life 7) Those who are at level 3 or higher on the Global Deterioration Scale (GDS) B. Healthy Control Group (individuals meeting all of the following criteria): 1) Participants aged 60 or older who have consented to research participation 2) Individuals who have a sufficient understanding of and provide consent for the research purpose and process 3) Participants with a Clinical Dementia Rating (CDR) score of 0. 4) Those who have a Clinical Dementia Rating Scale (CDR-Sum of Boxes, CDR-SB) score of 0 5) Those who have a Global Deterioration Scale (GDS) score of 1
Exclusion criteria
Exclusion criteria: (If any of the following applies, exclusions) 1) Those with schizophrenia-related disorders, substance and alcohol use disorders 2) Those who have difficulty wearing virtual reality VR equipment 3) Those with vision impairment – ??Those who cannot read regular text due to visual reasons even with glasses 4) Those with hearing impairment – ??Those who have difficulty understanding conversations due to auditory reasons even with hearing aids 5) Those who, in the clinician’s judgment, have difficulty communicating properly with the researcher and have difficulty receiving assistance from a guardian 6) Those who, in the clinician’s judgment, cannot read the consent form and have difficulty receiving assistance from a guardian 7) Others who cannot participate in this clinical trial according to the investigator’s judgment 8) Those who have participated or are participating in another interventional clinical trial related to cognitive function improvement within the past month 9) Those who have taken cognitive function improvement drugs (donepezil, rivastigmine, galantamine, memantine) within the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the AUC (Area under the curve) of the virtual reality cognitive function assessment program and the AUC of the existing cognitive function assessment program (MOCA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the sensitivity and specificity of the virtual reality cognitive function assessment program and the existing cognitive function assessment program (MOCA);Comparison of scores by virtual reality cognitive function assessment area between the mild cognitive impairment group and the healthy control group;Comparison of BS4MI(brief screening for four mental illnesses)-emotion stage, PROVE-DS score, and SGDS-K score in the virtual reality program;Comparison of immersion (PS, Presence Scale) scores by group between the mild cognitive impairment group and the healthy control group;SSQ (Simulator Sickness Questionnaire) evaluation before and after using the VR device | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungryul Lee
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed