A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition

Summary

To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.

Eligibility

Inclusion Criteria:

* Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60.
* The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive.
* The participant cohort will include at least 3 participants at each site exhibiting one of the following gait phenotypes: ataxic, hemiplegic and spastic. (Some participants may exhibit more than one phenotype).
* The participant cohort will include at least 3 participants at each site with a progressive form of MS.

Exclusion Criteria:

* Participants that are currently suffering from a musculoskeletal injury (e.g., sprain, fracture, strain, etc.) that limits their ability to use their full range of motion of any joint at the time of recruitment.
* Inability to provide informed consent.

Conditions1

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