Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Spain
  • United States
Trial Identifier:

NCT02952911 MA30162

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT02952911, MA30162 Trial Identifier
      Smartphone and Smartwatch Treatments
      Multiple Sclerosis Condition

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 55 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria

      For MS Participants:

      • Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
      • Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive

      For All Participants:

      • Weight: 45 to 110 kilograms (kg)
      Exclusion Criteria

      For MS Participants:

      • Severely ill and unstable participants as per investigator's discretion
      • Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment

      For All Participants:

      • Pregnant or lactating, or intending to become pregnant during the study

      For the latest version of this information please go to www.forpatients.roche.com

       

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