Neurological DisordersNCT05212727
Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
An observational study of Neurological Disorders, run by Innodem Neurosciences at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorders
- What is being tested?
- Eye-tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2022to 3 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neurological Disorders
- Being tested
- Eye-tracking
- Keywords
- Neurological disorders, Eye-tracking, Eye Movement Biomarkers
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. Receives: Device: Eye-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (9)
Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.
The BICAMS is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment. It includes the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R)
Measured: Baseline
Multiple sclerosis functional composite (MSFC) score, one time, at the day of enrolment.
A clinical trial outcome measure of assessing the severity of multiple sclerosis (MS) primarily. used in research. The score is based on a combination of timed tests of walking, arm function, and cognitive ability. It is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The MSFC can produce scores for each of the three individual measures as well as a composite score.
Measured: Baseline
The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.
The Montreal Cognitive Assessment (MoCA) is a brief 30-question cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment and Alzheimer's disease. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Measured: Baseline
The Mini-Mental State Exam (MMSE) score, one time, at the day of enrolment.
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly, it includes tests of orientation, attention, memory, language and visual-spatial skills. It consists of a series of questions and tests that can be used by clinicians to help diagnose dementia and to help assess its progression and severity.
Measured: Baseline
The Controlled Oral Word Association Test (COWAT) score, one time, at the day of enrolment.
The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds).
Measured: Baseline
The Trail Making Test (TMT) Parts A & B score, one time, at the day of enrolment.
The Trail Making Test (TMT) is a neuropsychological test that provides information on visual search, scanning, speed of processing, mental flexibility and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Measured: Baserline
The Hopkins Verbal Learning Test-Revised (HVLT-R) score, one time, at the day of enrolment.
The Hopkins Verbal Learning Test (HVLT-R) is a neuropsychological test that provides information on verbal learning and memory. The assessment consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall).
Measured: Baseline
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), one time, at the day of enrolment.
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), currently in its third version, is a questionnaire that evaluates patients' self-reported perceptions of their cognitive abilities and the effects of these cognitive changes on their Health-related quality of life (HRQOL).
Measured: Baseline
The Beck Anxiety Inventory (BAI), one time at the day of enrolment.
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Apr 2022
- Primary completion3 May 2024
- Study completion3 May 2024
Why it stopped: Not enough personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innodem Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212727
- Sponsor's protocol ID
- ETNA-NDHC
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
- ClinicalTrials.gov ID
- NCT05212727
- Acronym / sponsor ID
- ETNA-NDHC
- Conditions
- Neurological Disorders
- Keywords
- Neurological disorders, Eye-tracking, Eye Movement Biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough personnel
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Innodem NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: Eye-trackingParticipant with no evidence or history of significant neurodegenerative disorder affecting brain function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-trackingEye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. | Device | Healthy Control |
Primary outcome
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.
9 secondary outcomes
Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.
Time frame: Baseline
Multiple sclerosis functional composite (MSFC) score, one time, at the day of enrolment.
Time frame: Baseline
The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.
Time frame: Baseline
The Mini-Mental State Exam (MMSE) score, one time, at the day of enrolment.
Time frame: Baseline
The Controlled Oral Word Association Test (COWAT) score, one time, at the day of enrolment.
Time frame: Baseline
The Trail Making Test (TMT) Parts A & B score, one time, at the day of enrolment.
Time frame: Baserline
The Hopkins Verbal Learning Test-Revised (HVLT-R) score, one time, at the day of enrolment.
Time frame: Baseline
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), one time, at the day of enrolment.
Time frame: Baseline
The Beck Anxiety Inventory (BAI), one time at the day of enrolment.
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Not enough personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorders, run by Innodem Neurosciences at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.