RECRUITING

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

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

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.

Official Title

A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients

Quick Facts

Study Start:2023-07-01
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05781113

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 to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60.
  2. * The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive.
  3. * 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).
  4. * The participant cohort will include at least 3 participants at each site with a progressive form of MS.
  1. * 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.
  2. * Inability to provide informed consent.

Contacts and Locations

Study Contact

Bruce Ford
CONTACT
6132940620
bruce.ford@celestrahealth.com

Principal Investigator

Gauruv Bose, Dr.
PRINCIPAL_INVESTIGATOR
The Ottawa Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Celestra Health Systems

  • Gauruv Bose, Dr., PRINCIPAL_INVESTIGATOR, The Ottawa Hospital

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 Date2023-07-01
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis