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

Roche

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Smartphone and Smartwatch

Study type: Interventional

Funder types: Industry

Identifiers

NCT02952911

MA30162

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A: MS Participants

Experimental group

Description:

MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.

Treatment:

Device: Smartphone and Smartwatch

B: Healthy Controls

Other group

Description:

Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks.

Treatment:

Device: Smartphone and Smartwatch