NCT02952911

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

Completed NA Last updated 22 February 2019

What this trial tests

NA trial testing Smartphone and Smartwatch in Multiple Sclerosis in 100 participants. Completed in 4 May 2018.

Timeline

28 November 2016

Primary endpoint
4 May 2018

4 May 2018

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	100
Start date	28 November 2016
Primary completion	4 May 2018
Estimated completion	4 May 2018
Sites	2 locations across United States, Spain

Drugs / interventions tested

• Smartphone and Smartwatch

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sex and gender differences and biases in artificial intelligence for biomedicine and healthcare.
   Cirillo D, Catuara-Solarz S, Morey C, Guney E, et al · · 2020 · cited 204× · PMID 32529043 · DOI 10.1038/s41746-020-0288-5
2. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study.
   Midaglia L, Mulero P, Montalban X, Graves J, et al · · 2019 · cited 94× · PMID 31471961 · DOI 10.2196/14863
3. A smartphone sensor-based digital outcome assessment of multiple sclerosis.
   Montalban X, Graves J, Midaglia L, Mulero P, et al · · 2022 · cited 75× · PMID 34259588 · DOI 10.1177/13524585211028561
4. Interpretable deep learning for the remote characterisation of ambulation in multiple sclerosis using smartphones.
   Creagh AP, Lipsmeier F, Lindemann M, Vos M. · · 2021 · cited 14× · PMID 34253769 · DOI 10.1038/s41598-021-92776-x
5. Longitudinal Trend Monitoring of Multiple Sclerosis Ambulation Using Smartphones.
   Creagh AP, Dondelinger F, Lipsmeier F, Lindemann M, et al · · 2022 · cited 13× · PMID 36578776 · DOI 10.1109/ojemb.2022.3221306
6. Preliminary validity of the Draw a Shape Test for upper extremity assessment in multiple sclerosis.
   Graves JS, Ganzetti M, Dondelinger F, Lipsmeier F, et al · · 2023 · cited 12× · PMID 36563127 · DOI 10.1002/acn3.51705
7. Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test.
   Graves JS, Elantkowski M, Zhang YP, Dondelinger F, et al · · 2023 · cited 10× · PMID 37782540 · DOI 10.2196/46521
8. Neural correlates of digital measures shown by structural MRI: a post-hoc analysis of a smartphone-based remote assessment feasibility study in multiple sclerosis.
   Ganzetti M, Graves JS, Holm SP, Dondelinger F, et al · · 2023 · cited 10× · PMID 36469103 · DOI 10.1007/s00415-022-11494-0