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

NCT05781113 | Active Not Recruiting

• 1 other identifier: CelestraHealthmct1
• Study Type: observational
• Target: 90
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Participant Adherence

  To measure participant adherence, with respect to the wearable smart insoles and the associated smart phone app, for the purpose of MS disease monitoring. Adherence is defined as the collection by the participant of 15-minute walking samples 3x per week using the smart insoles and the associated smart phone app. Adherence will be assessed by calculating the number of tasks completed divided by the number of tasks prompted. \> 80% is deemed high adherence.

  6 months

• Clinician Acceptance

  To measure clinician acceptance of the solution, by confirming that the results are readily interpretable and useful to the clinician. Specifically, we will measure the satisfaction of clinicians using a 5-point Likert scale, as follows: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied.

  6 months

Secondary Outcomes (3)

• Gait Quality Measurement

  6 months

• Correlation between AI Gait Algorithms and Patience Perceptions

  6 months

• AI-based Identification of Gait Phenotypes

  6 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 90 PwMS equally spread across 3 sites / geographies, with approximately 10% of patients in the EDSS 0 to 2.5 range, 45% of patients in EDSS range 3-4.5 and 45% of patients in EDSS range 5 to 6.5 (some patients within this latter group will use walking supports in the form of AFOs, electronic foot braces, etc.).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celestra Health Systems: lead
• University of Ottawa: collaborator
• Barts & The London NHS Trust: collaborator
• The Ottawa Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

The Royal London Hospital

London, E1 IFR, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gauruv Bose, Dr.

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 23, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1); CA (1)