NCT06256731Completed
ETNA-MS Device Validation Study
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 5 Feb 2024
- Start date
- 12 Dec 2023
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Innodem Neurosciences
- Diseases
- Multiple sclerosis
- NCT number
- NCT06256731
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 12 Dec 2023 to the primary completion date, 12 Jun 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Other
- Having an EDSS score for which the desired sample size has been reached.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan Institute for Neurological Disorders Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Premier Neurology Research, P.C. Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Memorial Healthcare Coordinator of this site? Confirm its status | Owosso | United States | Unknown status |
| MS Integrated Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Rocky Mountain MS Research Group Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.