A multicenter, patient-control exploratory clinical trial for the clinical efficacy and safety assessment of a virtual reality-based cognitive assessment software (VARABOM-Diagnosis), aimed at assisting the mild cognitive impairment (MCI) screening diagnosis through cognitive function evaluation in patients with MCI.
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009132
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
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
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.
(Individuals meeting any of the following criteria will be excluded):
1) Presence of clinically significant internal medicine or neurological conditions, such as severe medical conditions or acute viral brain diseases, which could significantly impact mental health
2) Presence of mood disorders, schizophrenia spectrum disorders, substance use disorders, or alcohol use disorders
3) Difficulty wearing virtual reality (VR) equipment
4) Individuals with visual impairments - those unable to read normal text even with glasses for visual reasons
5) Individuals with hearing impairments - those who, even with hearing aids, find it difficult to understand conversation for auditory reasons
6) Those deemed by the clinician to have difficulty communicating effectively with the researcher, without the possibility of assistance from a guardian
7) Those deemed by the clinician to be unable to read the consent form, without the possibility of assistance from a guardian
8) Other individuals deemed by the investigator to be ineligible for participation in this clinical trial
9) Individuals who have taken cognitive enhancers (donepezil, rivastigmine, galantamine, memantine) within the last 6 months.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the Virtual Reality Cognitive Function Assessment Program through ROC Curve AUC (Area Under the Curve) based on the Total Score.;Collection of Adverse Events (including Medical Device Adverse Events, Serious Adverse Events/Medical Device Adverse Events): Assessment with the Simulator Sickness Questionnaire (SSQ) before and after the use of VR devices.
- Secondary Outcome Measures
Name Time Method Evaluation of Sensitivity and Specificity of Virtual Reality Cognitive Assessment Program Compared to Traditional Cognitive Assessment Programs (MOCA-K, MMSE, SNSB-? Subscale Scores);Comparison of Virtual Reality Cognitive Assessment Scores by Domain between Mild Cognitive Impairment Group and Healthy Control Group; Evaluation of the Validity, Total Scores, and Domain-specific Scores of the Virtual Reality Cognitive Assessment Program in Comparison to Conventional Cognitive Assessment Programs (MOCA-K, MMSE, SNSB-? Subscale Scores);Validity and Reliability Assessment of Psychological Evaluation Programs (PROVE-DS and BS4MI) Conducted with Virtual Reality Compared to Conventional Paper-Based Psychological Evaluation (SGDS-K)