ETNA-MS Device Validation Study

Description

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

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Study Overview

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Study Details

Study overview

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.

ETNA-MS Device Validation Study

ETNA-MS Device Validation Study

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Phoenix

MS Integrated Center, Phoenix, Arizona, United States, 85018

Farmington Hills

Michigan Institute for Neurological Disorders, Farmington Hills, Michigan, United States, 48334

Owosso

Memorial Healthcare, Owosso, Michigan, United States, 48867

Greenville

Premier Neurology Research, P.C., Greenville, South Carolina, United States, 29605

Salt Lake City

Rocky Mountain MS Research Group, Salt Lake City, Utah, United States, 84103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innodem Neurosciences,

Study Record Dates

2024-06-12