NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingN/A

Sponsor: Celestra Health Systems

Conditions: Multiple Sclerosis

Countries: United States, Canada, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (3)

Boston, Massachusetts, United States
Ottawa, Ontario, Canada
London, United Kingdom