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

Innodem Neurosciences

Status: Suspended

Conditions: Neurological Disorders

Treatments: Device: Eye-tracking

Study type: Observational

Funder types: Industry

Identifiers

NCT05212727

ETNA-NDHC

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

300 participants in 1 patient group

Healthy Control

Description:

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

Treatment:

Device: Eye-tracking