An AI-Based Prediction of Cognitive Capacity in Older Adults and Individuals With Mild Cognitive … (NCT07656389) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
An AI-Based Prediction of Cognitive Capacity in Older Adults and Individuals With Mild Cognitive Impairment During Virtual Reality Driving Tasks
Taiwan192 participantsStarted 2026-06-20
Plain-language summary
Driving ability in older adults is essential for independent mobility and social participation, yet declines under high cognitive load or distraction often lead to visual attention failures such as "look-but-fail-to-see," increasing crash risk. Older adults and individuals with mild cognitive impairment (MCI) show impairments in visual attention, executive control, and visuomotor integration, which are not adequately captured by conventional assessments. Virtual reality (VR) integrated with eye-tracking and upper-limb motion analysis enables ecologically valid simulation of driving scenarios and precise quantification of visuomotor behavior. However, current studies are limited by single-scenario designs, unimodal AI models, and insufficient integration of action-related data.
This study proposes a multi-phase framework: Year 1 develops an eye-movement-based AI model for MCI identification; Year 2 integrates multimodal data in VR driving tasks; and Year 3 establishes an explainable AI system with longitudinal validation. The study aims to advance cognitive assessment and develop a digital tool for early MCI detection and driving risk prediction.
Who can participate
Age range
30 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) a score of 23 or higher on the Montreal Cognitive Assessment; (2) a Clinical Dementia Rating score of 0 for cognitively healthy participants or 0.5 for participants with mild cognitive impairment (MCI); (3) healthy young adults aged between 30 and 39 years, and cognitively healthy older adults and participants with MCI aged between 65 and 85 years; (4) right-hand dominance; and (5) adequate visual function to complete VR and eye-tracking tasks, defined as corrected binocular visual acuity of at least 0.5 without severe visual field deficits.
Exclusion Criteria:
* (1) the presence or history of major psychiatric disorders or central nervous system diseases; (2) significant ocular diseases, such as untreated cataracts, active retinal diseases, moderate-to-severe or poorly controlled glaucoma, or marked visual field deficits beyond a specified level; (3) epilepsy; and (4) severe dizziness or VR-induced motion sickness.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses virtual reality driving tasks combined with eye movement tracking to assess cognitive capacity — given my diagnosis of mild cognitive impairment, does my doctor think my current cognitive and physical condition would make me a reasonable candidate to discuss participating in this kind of study?
2The trial is measuring something called 'Time to First Fixation' during VR driving — can my doctor explain what this measure tells researchers about cognitive decline, and whether findings from this type of study could eventually influence how MCI is monitored or diagnosed?
3Since this trial is listed as 'not yet recruiting,' what would my doctor recommend I focus on in the meantime — are there established clinical evaluations or standard-of-care options for MCI I should be pursuing now rather than waiting?
4The study involves virtual reality equipment and eye-tracking technology — are there any concerns my doctor has about whether I could tolerate a VR environment, especially if I have any balance issues, vision problems, or sensitivity to motion that might be relevant?
5This is a Phase NA observational-style study, meaning it's likely focused on measurement and prediction rather than treatment — can my doctor help me understand whether joining a study like this could complement my current care plan, or whether my time and energy might be better spent on other research or treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Fixation (TFF) within the Area of Interest