- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358598
Eye Movement Parameters and Cognitive Functions in Older Adults
The Relationship Between Eye Movement Parameters and Cognitive Functions in Older Adults
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yen Chin CHEN, Associated professor
- Phone Number: +886 7 5252000#7374
- Email: yenchin2427@gmail.com
Study Locations
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Kaohsiung City, Taiwan
- Kaohsiung Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants are aged 65 years or older and have completed a comprehensive geriatric assessment (CGA) in the outpatient clinic.
Exclusion Criteria:
- Participants are under 65 years of age or those who ar are unable to comply with study procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy group-patients with intact cognitive function
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Mild cognitive impairment group-patients with mild cognitive impairment
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Dementia group-patients with severe cognitive impairment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eye-tracking measurement
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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Eye movement behavior will be assessed as an objective measure of cognitive control in older adults. Eye-tracking data will be collected using the J7EF Gaze Smart Glasses (Jorjin Technologies), a non-invasive wearable eye-tracking system with a sampling frequency of 30 Hz. Participants will perform standardized visual tasks while eye movement behavior is recorded. Outcome measures will include task-related eye movement patterns, such as gaze behavior and saccadic performance, which reflect attentional control and higher-order cognitive processing. Alterations in these eye movement parameters have been associated with cognitive impairment. Eye movement measures will be used to characterize differences in cognitive function across participant groups. |
A single assessment is conducted at one study visit (cross-sectional design).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mini-Mental State Examination (MMSE)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool originally developed by Folstein and McHugh in 1975 (Folstein et al., 1975). It consists of 30 items assessing six domains of cognitive function: orientation, attention, memory, language, verbal comprehension, praxis, and constructional ability. Higher scores indicate better cognitive function. A total score between 24 and 30 suggests intact cognitive function; scores between 18 and 23 are indicative of mild cognitive impairment; and scores from 0 to 17 reflect moderate to severe cognitive impairment. In the present study, the MMSE is used to classify adults aged 65 years and older into cognitive status groups, including a cognitively healthy group, a mild cognitive impairment (MCI) group, and a dementia group, based on established score thresholds. |
A single assessment is conducted at one study visit (cross-sectional design).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eye-Tracking Task 1: Horizontal Fixation Task (HFT)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The FXS task is designed to measure fixation stability.
Participants are instructed to fixate on a white dot, that appears sequentially at different screen locations: initially in the center, then alternately to the left and right sides of the screen.Each position is maintained for 5 seconds, during which participants are instructed to maintain their gaze on the white dot.
The sequence proceeds as follows: Center (5 seconds), right side (5 seconds), left side (5 seconds), and return to center (5 seconds).
The task duration is approximately 20 seconds.
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A single assessment is conducted at one study visit (cross-sectional design).
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Eye-Tracking Task 2: Vertical Fixation Task (VFT)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The Vertical Fixation Task is designed to assess vertical saccadic eye movements and fixation stability.
A white fixation dot is sequentially displayed on a black background at specific vertical locations.
The target is presented at the center of the screen and then alternates between upper and lower positions at 5-second intervals (center-upper-lower-center), with a total task duration of approximately 20 seconds.
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A single assessment is conducted at one study visit (cross-sectional design).
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Eye-tracking Task 3: Horizontal Pursuit Task (HPT)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The HPT is designed to evaluate participants' ability to perform smooth horizontal pursuit eye movements.
A white dot then appears at the center of a black screen, prompting participants to fixate and track the dot continuously as it begins moving horizontally.
The stimulus moves smoothly and repeatedly from left to right and back across the screen.
Participants are instructed to visually follow the moving dot toward to left and right side without shifting their head position.
The task duration is approximately 30 seconds.
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A single assessment is conducted at one study visit (cross-sectional design).
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Eye-Tracking Task 4: Vertical Pursuit Task (VPT)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The VPT is designed to evaluate participants' ability to perform smooth horizontal pursuit eye movements.
A white dot then appears at the center of a black screen, prompting participants to fixate and track the dot continuously as it begins moving vertically.
The stimulus moves smoothly and repeatedly from up to down across the screen.
Participants are instructed to visually follow the moving dot toward to up and down side without shifting their head position.
The task duration is approximately 30 seconds.
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A single assessment is conducted at one study visit (cross-sectional design).
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Eye-Tracking Task 5: Horizontal Saccade Task (HST)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The HST is designed to evaluate rapid, reflexive saccadic eye movements in response to abrupt horizontal target shifts.
A white fixation dot appears at the center of the screen and then jumps alternately between the far left and far right positions.
Participants are instructed to track the dot continuously from left to right for the entire duration of the task (approximately 30 seconds).
Each positional shift is abrupt, requiring quick and accurate horizontal saccades.
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A single assessment is conducted at one study visit (cross-sectional design).
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Eye-Tracking Task 6: Vertical Saccade Task (VST)
Time Frame: A single assessment is conducted at one study visit (cross-sectional design).
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The VST is designed to evaluate rapid, reflexive saccadic eye movements in response to abrupt horizontal target shifts.
A white fixation dot appears at the center of the screen and then jumps alternately between the far up and far down positions.
Participants are instructed to track the dot continuously from up to down for the entire duration of the task (approximately 30 seconds).
Each positional shift is abrupt, requiring quick and accurate horizontal saccades.
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A single assessment is conducted at one study visit (cross-sectional design).
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSVGH24-CT10-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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