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

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02952911

Run by

Hoffmann-La Roche

People needed

100

Starts

2016-11-28

Expected to finish

2018-05-04

Last updated by the study team

2019-02-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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