Magnetic Resonance Imaging (MRI) and Eye-tracking Predictive Markers of Cognitive Ageing.
NCT ID: NCT06058897
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-03-22
2028-03-22
Brief Summary
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Detailed Description
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The study will assess, in cognitively-healthy older volunteers from the INSPIRE cohort (n=100, over 60 years old), MRI and pupillometry markers of LC integrity, LC-forebrain connectivity and LC activity. We aim at investigating the relationship between LC biomarkers and cognitive status. Four experimental visits will be conducted by each participant, every 6 months over an 18-month period. Visits V1 and V4 will include MRI, eye-tracking and detailed cognitive exams. Visits V2 and V3 will include a detailed cognitive exam.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental
MRI, eye-tracking and cognitive exams will be completed by subjects.
MRI
MRI examinations will be conducted on the 3T MRI technical platform. During the MRI examination, images reflecting the integrity of the LC (quantification of neuromelanin as well as its functional connections with the different brain regions (resting functional MRI) will be acquired. High-resolution T1 and T2 weighted images of the the entire brain will also be acquired for the volumetry of cerebral areas.
eye-tracking
Eye tracking examinations will be conducted using an EyeBrain medical device (class IIa) developed by Suricog. This eye tracker will be installed in a box, in an experimental room. The eye tracker is combined with a computer to present visual cognitive tasks. Pupillary dilation/constriction measurements will be acquired at rest (when fixing a cross presented on the screen) and during the performance of different cognitive tasks (exploration and processing of scenes visuals, reading texts, making saccades or anti-saccades when presenting visual targets). These pupillary measurements will then be linked to the memorization of the stimuli presented, this recognition being tested at the end of the exam.
cognitive exams
Cognitive measures will be acquired during an evaluation session through interactive cognitive exercises. These exercises are developed using tools offered by Covirtua Healthcare (Covirtua Cognition software). Some exercises will test cognitive systems a priori dependent on NA release (episodic memory, working memory, selective attention, selective inhibition, planning) and other a priori independent of NA (semantic memory: categorization, naming).
Interventions
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MRI
MRI examinations will be conducted on the 3T MRI technical platform. During the MRI examination, images reflecting the integrity of the LC (quantification of neuromelanin as well as its functional connections with the different brain regions (resting functional MRI) will be acquired. High-resolution T1 and T2 weighted images of the the entire brain will also be acquired for the volumetry of cerebral areas.
eye-tracking
Eye tracking examinations will be conducted using an EyeBrain medical device (class IIa) developed by Suricog. This eye tracker will be installed in a box, in an experimental room. The eye tracker is combined with a computer to present visual cognitive tasks. Pupillary dilation/constriction measurements will be acquired at rest (when fixing a cross presented on the screen) and during the performance of different cognitive tasks (exploration and processing of scenes visuals, reading texts, making saccades or anti-saccades when presenting visual targets). These pupillary measurements will then be linked to the memorization of the stimuli presented, this recognition being tested at the end of the exam.
cognitive exams
Cognitive measures will be acquired during an evaluation session through interactive cognitive exercises. These exercises are developed using tools offered by Covirtua Healthcare (Covirtua Cognition software). Some exercises will test cognitive systems a priori dependent on NA release (episodic memory, working memory, selective attention, selective inhibition, planning) and other a priori independent of NA (semantic memory: categorization, naming).
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination score ≥ 27 on 30
* Access to a web connection from participant's or relative's home and regular use of web surfing
* Signature of the informed consent
* Affiliated to a social security scheme
Exclusion Criteria
* Ophthalmic pathology impacting eye-tracking measures
* Neurological or psychiatric pathology
* Person under guardianship or curatorship
Contraindications to MRI examination:
* Pacemaker or cardiac defibrillator
* Implanted material activated by an electrical, magnetic or mechanical system
* Haemostatic clips for intracerebral aneurysms or carotid arteries
* Orthopedic implants
* Claustrophobia
Ophthalmological pathologies impacting eye tracking measurements:
* Glaucoma
* Age-related macular degeneration
* Unoperated cataract
60 Years
100 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Pierre PAYOUX, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre PAYOUX, MD
Role: primary
Florence REMY, PhD
Role: backup
Other Identifiers
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RC31/22/0357
Identifier Type: -
Identifier Source: org_study_id