Monitoring of Multiple Sclerosis (MS) Participants With the Use of Dig
Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Smartphone and Smartwatch
What it measured
Main measures
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks
Week 12
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
Week 24
Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Week 12
Quality of life (reported by participants)Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Week 24
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 55 · EDSS 0.0 to 5.5
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Neural correlates of digital measures shown by structural MRI: a post-hoc analysis of a smartphone-based remote assessment feasibility study in multiple sclerosis.J Neurol · 2023
Results
A smartphone sensor-based digital outcome assessment of multiple sclerosis.Mult Scler · 2022
Results
Graves JS, Elantkowski M, Zhang YP, Dondelinger F, Lipsmeier F, Bernasconi C, Montalban X, Midaglia L, Lindemann M. Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test. JMIR Form Res. 2023 Oct 2;7:e46521. doi: 10.2196/46521.Results
Midaglia L, Mulero P, Montalban X, Graves J, Hauser SL, Julian L, Baker M, Schadrack J, Gossens C, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J Med Internet Res. 2019 Aug 30;21
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History
Started
Nov 2016
Main results due
May 2018
Finished
May 2018