Multiple SclerosisETNA-MSNCT06256731
ETNA-MS Device Validation Study
An observational study of Multiple Sclerosis, run by Innodem Neurosciences at 5 sites in United States.
Trial summary
The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Eye-Tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Dec 2023to 12 Jun 2024
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Our target sample size for the MS group is 60. Eligible patients with MS will be selected and categorized based on their EDSS score.
Who may be able to join
- Able to provide informed consent
- Aged 18 years or older at the time of enrolment
- Able to read in either English, Spanish or French
- Able to read the oculomotor task on-screen instructions at the testing distance (45 cm) with or without corrective lenses
- Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS))
- Neurologist-determined EDSS score between 1.0-4.5
Who cannot join
- Evidence or medical history of a neuropsychiatric disorder such as schizophrenia and autism, which are known to impair eye movements and oculomotor control.
- Presence of comorbid neurological conditions causing significant eye movement anomalies (such as strabismus, cranial nerve palsy, stroke-causing hemianopsia).
- Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
- Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics, and anticonvulsants) within the past three months.
- Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments.
- Having an EDSS score for which the desired sample size has been reached.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
Premier Neurology Research, P.C.
Greenville, South Carolina, 29605
Memorial Healthcare
Owosso, Michigan, 48867
MS Integrated Center
Phoenix, Arizona, 85018
Rocky Mountain MS Research Group
Salt Lake City, Utah, 84103
About this study
The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients. Effectiveness of the device will be assessed by the level of agreement between the EDSS estimated by the device and the actual scores measured by the neurologist in-person assessments.
Read the detailed description
This study will use a multi-site cross-sectional design in a single cohort of Multiple Sclerosis (MS) patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.
- Conditions
- Multiple Sclerosis
- Being tested
- Eye-Tracking
- Medical subject headings
- Multiple Sclerosis
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 |
|---|---|---|
| Single cohort of MS patients with EDSS 1.0-4.5 | Confirmed diagnosis of MS with an EDSS score ranging from 1.0 and 4.5. Receives: Device: Eye-Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS.
Evaluate the average level of agreement (within +/- 0.5 EDSS score) between the device-estimated EDSS score and the ground truth, that is the true EDSS score as established by a certified neurologist. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Measured: Day 1
Secondary outcomes (6)
Validate that the ETNA-MS device has good test-retest reliability for estimating the EDSS.
Evaluate the level of agreement between device outputs from two repeated eye-tracking tests.
Measured: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Evaluate the level of agreement between the device-estimated clinical scores and the ground truth scores, and between the device-estimated composite scores and the ground truth composite scores. The Brief International Cognitive Assessment for MS (BICAMS) is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment, which includes the Symbol Digit Modalities Test (SDMT). The test presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to voice or write the digit associated with each symbol as rapidly as possible for 90 seconds. The test is scored on the number correct answers over the 90 second time span. A higher score represents lower levels of disability.
Measured: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Evaluate the level of agreement between the device-estimated clinical scores and the ground truth scores, and between the device-estimated composite scores and the ground truth composite scores. The Brief International Cognitive Assessment for MS (BICAMS) is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment, which includes the Brief Visuospatial Memory Test-Revised (BVMT-R). In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12. There are three learning trials, and the test is scored on the total number of points earned over the three learning trials. A higher score represents lower levels of disability.
Measured: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Evaluate the level of agreement between the device-estimated clinical scores and the ground truth scores, and between the device-estimated composite scores and the ground truth composite scores. The Brief International Cognitive Assessment for MS (BICAMS) is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment, which includes the Rey Auditory Verbal Learning Test (RAVLT). In this test, patients listen to a 15-word list and report as many of the times as possible. There is no instruction as to the order in which items are recalled. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials. The test is scored on the total number of recalled items over the five learning trials. The delayed recall, second list, and recognition trials are not administered in the context of this study. A higher score represents lower levels of disability.
Measured: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC).
Evaluate the level of agreement between the device-estimated clinical scores and the ground truth scores, and between the device-estimated composite scores and the ground truth composite scores. The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. The test is scored on the time taken to walk the two trials of the 25 feet walk. A higher score represents higher levels of disability.
Measured: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC).
Evaluate the level of agreement between the device-estimated clinical scores and the ground truth scores, and between the device-estimated composite scores and the ground truth composite scores. The 9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The test is scored on the time taken to complete each trial for each hand. A higher score represents higher levels of disability.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start12 Dec 2023
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Innodem Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256731
- Sponsor's protocol ID
- IN-MS-001
- Acronym
- ETNA-MS
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 1 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETNA-MS Device Validation Study
- ClinicalTrials.gov ID
- NCT06256731
- Acronym / sponsor ID
- ETNA-MS / IN-MS-001
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Innodem NeurosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 13 Feb 2024 (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.
The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients. Effectiveness of the device will be assessed by the level of agreement between the EDSS estimated by the device and the actual scores measured by the neurologist in-person assessments.
Detailed description
This study will use a multi-site cross-sectional design in a single cohort of Multiple Sclerosis (MS) patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort of MS patients with EDSS 1.0-4.5 | – | Device: Eye-TrackingConfirmed diagnosis of MS with an EDSS score ranging from 1.0 and 4.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our target sample size for the MS group is 60. Eligible patients with MS will be selected and categorized based on their EDSS score.
Key inclusion criteria (6 listed)
- Able to provide informed consent
- Aged 18 years or older at the time of enrolment
- Able to read in either English, Spanish or French
- Able to read the oculomotor task on-screen instructions at the testing distance (45 cm) with or without corrective lenses
- Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS))
Key exclusion criteria (6 listed)
- Evidence or medical history of a neuropsychiatric disorder such as schizophrenia and autism, which are known to impair eye movements and oculomotor control.
- Presence of comorbid neurological conditions causing significant eye movement anomalies (such as strabismus, cranial nerve palsy, stroke-causing hemianopsia).
- Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
- Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics, and anticonvulsants) within the past three months.
- Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments.
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 | Single cohort of MS patients with EDSS 1.0-4.5 |
Primary outcome
Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS.
Time frame: Day 1
Evaluate the average level of agreement (within +/- 0.5 EDSS score) between the device-estimated EDSS score and the ground truth, that is the true EDSS score as established by a certified neurologist. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
6 secondary outcomes
Validate that the ETNA-MS device has good test-retest reliability for estimating the EDSS.
Time frame: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Time frame: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Time frame: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
Time frame: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC).
Time frame: Day 1
Validate the effectiveness of the ETNA-MS device to estimate the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC).
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Innodem Neurosciences at 5 sites in United States.
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 6 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: finished, as of the sponsor's last update on 1 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 5 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS. (time frame: Day 1). 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 1 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.