Wearable device for monitoring changes in Multiple Sclerosis
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
This study is testing a smart insole and app to see if it can help people with Multiple Sclerosis track their walking and changes in their condition every day.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Celestra Health Systems Industry-sponsored |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05781113 on ClinicalTrials.gov |
What this trial studies
This study evaluates a smart insole wearable device and smartphone app designed to monitor the condition of patients with Multiple Sclerosis (MS) on a daily basis. It focuses on objectively measuring gait, which is significantly impaired in 75% of MS patients, using an AI-based digital biomarker. By collecting gait metrics in the patient's home environment, the study aims to provide clinicians with valuable data to track disease progression and tailor treatment plans more effectively. The approach seeks to enhance the understanding of subtle changes in MS that current clinical assessments may overlook.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a confirmed diagnosis of Multiple Sclerosis and an EDSS score of 6.5 or lower.
Not a fit: Patients with musculoskeletal injuries that limit their mobility or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more accurate monitoring of MS progression and improved personalized treatment strategies for patients.
How similar studies have performed: Other studies utilizing wearable technology for monitoring chronic conditions have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Completed)
- The Royal London Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gauruv Bose, Dr. — The Ottawa Hospital
- Study coordinator: Bruce Ford
- Email: bruce.ford@celestrahealth.com
- Phone: 6132940620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.