NCT05212727

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

January 18, 2022

Last Update Submit

March 4, 2024

Conditions

Neurological Disorders

Keywords

Neurological disordersEye-trackingEye Movement Biomarkers

Outcome Measures

Primary Outcomes (1)

  • Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.

    The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.

    Baseline

Secondary Outcomes (9)

  • Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.

    Baseline

  • Multiple sclerosis functional composite (MSFC) score, one time, at the day of enrolment.

    Baseline

  • The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.

    Baseline

  • The Mini-Mental State Exam (MMSE) score, one time, at the day of enrolment.

    Baseline

  • The Controlled Oral Word Association Test (COWAT) score, one time, at the day of enrolment.

    Baseline

  • +4 more secondary outcomes

Study Arms (1)

Healthy Control

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

Device: Eye-tracking

Interventions

Eye-trackingDEVICE

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

Healthy Control

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innodem Neurosciences

Montreal, Quebec, H2T 2A4, Canada

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Eye-Tracking Technology

Intervention Hierarchy (Ancestors)

Eye Movement MeasurementsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 28, 2022

Study Start

April 15, 2022

Primary Completion

May 3, 2024

Study Completion

May 3, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

CA(1)