Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Eye-tracking
- Conditions
- Neurological Disorders
- Sponsor
- Innodem Neurosciences
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.
- Status
- Terminated
- Last Updated
- 26 days ago
Overview
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.
Investigators
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).
Arms & Interventions
Healthy Control
Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.
Intervention: Eye-tracking
Outcomes
Primary Outcomes
Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.
Time Frame: Baseline
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.
Secondary Outcomes
- Multiple sclerosis functional composite (MSFC) 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 Hopkins Verbal Learning Test-Revised (HVLT-R) 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)
- Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.(Baseline)
- The Beck Anxiety Inventory (BAI), one time at the day of enrolment.(Baseline)
- The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.(Baseline)
- The Trail Making Test (TMT) Parts A & B score, one time, at the day of enrolment.(Baserline)
- The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), one time, at the day of enrolment.(Baseline)