Monitoring progression in multiple sclerosis using wearables
Multiple Sclerosis Prediction and Monitoring of Progression Study
This study is testing whether wearable devices can help track symptoms of multiple sclerosis in real-time to see if they can better spot early signs of the disease getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05685784 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the detection of progressive multiple sclerosis (MS) by utilizing wearable technology to monitor patients' symptoms in real-time. By collecting data on various parameters such as walking speed and sleep patterns at home, the study seeks to identify digital biomarkers that indicate early signs of disease progression. The effectiveness of these wearables will be validated against established clinical assessments like polysomnography and gait analysis conducted in specialized labs. This approach aims to provide a more sensitive and comprehensive understanding of MS progression compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-60 with relapsing-remitting, primary progressive, or secondary progressive multiple sclerosis who have an EDSS score of 6.5 or lower.
Not a fit: Patients with severe comorbidities or those who have experienced recent clinical relapses or new lesions on MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of progressive multiple sclerosis, improving patient outcomes.
How similar studies have performed: While the use of digital biomarkers in MS is an emerging field, previous studies have shown promise in utilizing technology for monitoring disease progression, making this approach both innovative and relevant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsing Remitting (RR) or Primary Progressive (PPMS) MS as defined by 2017 Mc Donald criteria, or Secondary Progressive (SPMS) according to Lorscheider criteria AND having an EDSS ≤ 6.5 * Healthy control * Non-MS Patient with an indication for polysomnography * Age 18-60 years inclusive Exclusion Criteria: * Patients who were prescribed 4-aminopyridin during the last 30 days. * Patients with severe cardiac, pneumological, neurological, hematological, immunological, infectious, rheumatoid, endocrinological, gastro-intestinal, urological comorbidity that may interfere with outcome measures as determined by the investigators. * Confirmed clinical relapses or new lesions on MRI during the last six months * Known allergy to electrodes used as part of the study protocol * Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.
Where this trial is running
Ghent, Oost-Vlaanderen
- University Hospital Ghent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Guy Laureys, MD, PhD — University Hospital, Ghent
- Study coordinator: Liesbeth Van Hijfte, Master
- Email: liesbeth.vanhijfte@uzgent.be
- Phone: +3293321168
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.