Using a smartphone app to monitor Multiple Sclerosis progression
MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect
This study is testing a smartphone app that helps people with Multiple Sclerosis track their symptoms at home to see if it can improve monitoring and understanding of their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Ad scientiam Academic / other |
| Locations | 36 sites (San Diego, California and 35 other locations) |
| Trial ID | NCT05816122 on ClinicalTrials.gov |
What this trial studies
This study evaluates the MSCopilot® Detect smartphone application designed for at-home monitoring of patients with Multiple Sclerosis (MS). It aims to standardize remote monitoring to accurately assess disease progression due to Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study will also assess the app's safety, usability, and patient satisfaction, while exploring its ability to predict changes in Expanded Disability Status Scale (EDSS) scores and correlate with biomarkers like MRI and neurofilament light chain. Patients will download the app and participate in monitoring their condition remotely.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 65 with relapsing-remitting or secondary progressive MS, stable for the last three months, and with a disease duration of over five years.
Not a fit: Patients with medically unstable conditions or those unable to use a smartphone will not benefit from this study.
Why it matters
Potential benefit: If successful, this app could enable earlier detection of MS progression, leading to timely interventions and improved patient outcomes.
How similar studies have performed: While the use of mobile applications for disease monitoring is gaining traction, this specific approach with MSCopilot® Detect is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients living with RRMS or SPMS, aged 30 to 65 * EDSS score between 2.5 to 6.5 points * With a disease duration \> 5 years * Clinically stable during the last 3 months before inclusion (no relapses, no disability progression) * No change in the DMT\* during the last 3 months before inclusion * Receiving optimal symptomatic treatments at baseline (clinician's judgment) * Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion * Able to use a smartphone * Able to read language in wich the mobile application is available and able to understand pictograms. * Applicable to patients enrolled in France only: affiliated to a social security system. Exclusion Criteria: * Medically unstable conditions that may hinder patient's ability to comply with the study procedures * Inability to use a smartphone or MSCopilot® Detect application * Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR) * Pregnancy and nursing women * Persons under guardianship or curatorship * Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment) * Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.
Where this trial is running
San Diego, California and 35 other locations
- Jennifer Graves — San Diego, California, United States (Recruiting)
- Joash Lazarus Sr. — Atlanta, Georgia, United States (Recruiting)
- Daniel Wynn — Northbrook, Illinois, United States (Recruiting)
- Craig E. Herrman — Indianapolis, Indiana, United States (Recruiting)
- Jennifer Feng — New Orleans, Louisiana, United States (Recruiting)
- Robert Naismith — St Louis, Missouri, United States (Recruiting)
- Aaron Boster — Columbus, Ohio, United States (Recruiting)
- Gabriel Pardo — Oklahoma City, Oklahoma, United States (Recruiting)
- Vijayshree Yadav — Portland, Oregon, United States (Recruiting)
- Leorah Freeman — Austin, Texas, United States (Recruiting)
- Galina Vorobeychik — Burnaby, Canada (Recruiting)
- Mark Freedman — Ottawa, Canada (Not_yet_recruiting)
- St. Michael's Hospital — Toronto, Canada (Not_yet_recruiting)
- Robert Carruthers — Vancouver, Canada (Recruiting)
- University Hospital of Southern Denmark — Esbjerg, Denmark (Recruiting)
- Finn Sellebjerg — Glostrup, Denmark (Recruiting)
- Sivagini Prakash — Viborg, Denmark (Not_yet_recruiting)
- Hôpital Roger Salengro — Lille, France (Recruiting)
- Cécile Donzé — Lomme, France (Recruiting)
- Adil Maarouf — Marseille, France (Recruiting)
- Mikael Cohen — Nice, France (Recruiting)
- Bertrand Bourre — Rouen, France (Recruiting)
- Boris-Alexander Kallman — Bayreuth, Germany (Recruiting)
- Felix Bischof — Böblingen, Germany (Not_yet_recruiting)
- Universitätsklinikum Carl Gustav Carus — Dresden, Germany (Recruiting)
- Rupert Knoblich — Erbach, Germany (Recruiting)
- Damiano Paolicelli — Bari, Italy (Not_yet_recruiting)
- Emilio Portaccio — Florence, Italy (Recruiting)
- Emanuele D'Amico — Foggia, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- Gary Álvarez Bravo — Girona, Spain (Recruiting)
- Enric Monreal — Madrid, Spain (Recruiting)
- University Hospital San Carlos — Madrid, Spain (Recruiting)
- Ana Alonso — Málaga, Spain (Recruiting)
- Miguel Llaneza — Oviedo, Spain (Not_yet_recruiting)
- Jesùs Martin — Zaragoza, Spain (Recruiting)
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.