Clinical trial NCT05212727: Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
Official title: Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Neurological Disorders
Keywords: Neurological disorders
Eye-tracking
Eye Movement Biomarkers
Lead sponsor: Innodem Neurosciences
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be obtained from 300 healthy adult individuals across the age spectrum. We will stop recruiting participants of a certain age once one of the following age groups has reached 100 participants:

18-40 40-60 60 and over

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.
timeFrame: Baseline
Secondary outcomes:
measure: Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: Multiple sclerosis functional composite (MSFC) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: The Mini-Mental State Exam (MMSE) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: The Controlled Oral Word Association Test (COWAT) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: The Trail Making Test (TMT) Parts A & B score, one time, at the day of enrolment.
timeFrame: Baserline
measure: The Hopkins Verbal Learning Test-Revised (HVLT-R) score, one time, at the day of enrolment.
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), one time, at the day of enrolment.
timeFrame: Baseline
measure: The Beck Anxiety Inventory (BAI), one time at the day of enrolment.
timeFrame: Baseline
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Innodem Neurosciences
state: Quebec
Study officials:
References: