An AI-Based Prediction of Cognitive Capacity in Older Adults and Individuals With Mild Cognitive Impairment During Virtual Reality Driving Tasks

NCT07656389 | Not Yet Recruiting

• 1 other identifier: A-ER-115-039
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Virtual Reality; Eye Movement Disorder; Multimodal Monitoring; Older Adults

Outcome Measures

Primary Outcomes (1)

• Time to First Fixation (TFF) within the Area of Interest

  Time to First Fixation (TFF) is defined as the time interval from event onset (t₀) to the participant's first fixation within the predefined Area of Interest (AOI). A shorter TFF indicates faster attentional orienting. Units of Measure: milliseconds (ms) for each predefined AOI/event condition.

  Baseline

Secondary Outcomes (13)

• Number of Fixations on the Area of Interest

  Baseline

• Total Fixation Duration (TFD) on the Area of Interest

  Baseline

• Steering Reaction Time

  Baseline

• Steering Reversal Rate (SRR)

  Baseline

• Speed Change During Driving Tasks

  Baseline

Study Arms (3)

Young Adults

Healthy young adults (aged 30-39 years) with no history of neurological or psychiatric disorders. Participants will complete standardized virtual reality (VR) driving tasks with integrated eye-tracking and upper-limb motion recording to establish normative visuomotor and cognitive performance benchmarks.

Cognitively Healthy Older Adults

Community-dwelling older adults (≥65 years) with normal cognitive function based on standardized screening (e.g., MoCA within normal range). Participants will undergo the same VR-based assessments to examine age-related changes in visual attention, executive control, and visuomotor coupling.

Mild Cognitive Impairment (MCI)

Older adults clinically identified with mild cognitive impairment according to established diagnostic criteria. Participants will complete identical VR driving tasks to investigate alterations in visual search behavior, attentional control, and visuomotor integration, and to support development of predictive AI models for cognitive decline and driving risk.

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include healthy young adults aged 30-39 years, as well as cognitively healthy older adults and individuals with mild cognitive impairment (MCI) aged 65-85 years.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

Hsiu-Yun Hsu, Ph.D

CONTACT

886-6-2353535; hyhsu@mail.ncku.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 18, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

TW (1)