RECRUITING

ETNA-MS Device Validation Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

ETNA-MS Device Validation Study

Quick Facts

Study Start:2023-12-12

Study Completion:2024-06-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06256731

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

MS Integrated Center

Phoenix, Arizona, 85018

United States

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, 48334

United States

Memorial Healthcare

Owosso, Michigan, 48867

United States

Premier Neurology Research, P.C.

Greenville, South Carolina, 29605

United States

Rocky Mountain MS Research Group

Salt Lake City, Utah, 84103

United States

Collaborators and Investigators

Sponsor: Innodem Neurosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12

Study Completion Date2024-06-12

Study Record Updates

Study Start Date2023-12-12

Study Completion Date2024-06-12

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis