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Summary

for people ages 18–55 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Keywords

Multiple Sclerosis Sclerosis

Eligibility

You can join if…

Open to people ages 18–55

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)

You CAN'T join if...

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

Locations

  • UCSF- Multiple Sclerosis Centre; Department of Neurology
    San Francisco, California, CA94158, United States
  • Hospital Vall d'Hebron; Servicio de Neurología
    Barcelona, 08035, Spain

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02952911
Study Type
Interventional
Last Updated
May 1, 2018