Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders

NCT ID: NCT05212727

Last Updated: 2024-03-05

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-05-03

Brief Summary

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This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by neurological disorders and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of neurological disorders and associated cognitive changes.

Detailed Description

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Conditions

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Neurological Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Control

Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.

Eye-tracking

Intervention Type DEVICE

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Interventions

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Eye-tracking

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years old and above
* A score of ≥ 26 on the Montreal Cognitive Assessment (MoCA)
* Able to provide informed consent
* Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc are permitted).

Exclusion Criteria

* Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
* Evidence or history of significant neurological disorder (e.g. MS, PD, ALS, Dementia)
* Use of prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics, and anticonvulsants.
* Diagnosed with an active substance use disorder.
* History of stroke.
* Recent traumatic brain injury (within the last 6 months).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innodem Neurosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Innodem Neurosciences

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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ETNA-NDHC

Identifier Type: -

Identifier Source: org_study_id

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