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Not recruiting

ETNA-MS

Sponsor:

Innodem Neurosciences

Code:

NCT06256731

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eye-Tracking

Study Details

Brief 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. 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.

Conditions

Multiple Sclerosis

Study ID

NCT06256731

Start date

Dec 12, 2023

Status verified date

Feb, 2024

Completion date

Jun 12, 2024

Anticipated

Primary completion date

Jun 12, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Eye-Tracking

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

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 ]

Central Contacts and Locations

Locations

MS Integrated Center

Recruiting

Phoenix, Arizona, United States, 85018

Contacts

Brandon McCravey

480-471-6132bmccravey@prcresearcheducation.com

Principal Investigator:

Barry Hendin, MD

Memorial Healthcare

Recruiting

Owosso, Michigan, United States, 48867

Contacts

Virginia Williamson, BSN RN

989-725-9424vwilliamson@memorialhealthcare.org

Principal Investigator:

Jeanie Cote, MD

Premier Neurology Research, P.C.

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Rebecca Sellers

864-655-4005rebecca.s@premier-neuro.com

Principal Investigator:

Mary Hughes, MD

Rocky Mountain MS Research Group

Recruiting

Salt Lake City, Utah, United States, 84103

Contacts

Tammy Hoyt

801-408-5711thoyt@rmmsc.com

Principal Investigator:

April Erwin, MD

More Information

Sponsor

Innodem Neurosciences

Last update posted

Feb 13, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Innodem Neurosciences on 2024-02-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.