Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review.

Marcello De Angelis,Marcello Moccia,Luigi Lavorgna,Roberta Lanzillo,Martina Petruzzo,Vincenzo Brescia Morra,Antonio Carotenuto

doi:10.3390/jcm10112328

Marcello De Angelis, Marcello Moccia + Show 5 more

Open Access

https://doi.org/10.3390/jcm10112328

Copy DOI

Abstract

Clinical trials in multiple sclerosis (MS) have been including digital technology tools to overcome limitations in treatment delivery and disease monitoring. In March 2020, we conducted a systematic search on pubmed.gov and clinicaltrials.gov databases (with no restrictions) to identify all relevant published and unpublished clinical trials, in English language, including MS patients, in which digital technology was applied. We used “multiple sclerosis” and “clinical trial” as the main search words, and “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Digital technology has been used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms (e.g., electronic recording of motor performance). Other clinical trials have been using digital technology for monitoring symptoms that would be otherwise difficult to detect (e.g., fatigue, balance), for measuring treatment adherence and side effects, and for self-assessment purposes. Collection of outcome measures is progressively shifting from paper-based on site, to internet-based on site, and, in the future, to internet-based at home, with the detection of clinical and treatment features that would have remained otherwise invisible. Similarly, remote interventions provide new possibilities of motor and cognitive rehabilitation.

Highlights

Multiple sclerosis (MS) is the most common cause of neurological disability in young adults [1]
We found eight studies out of 35 (23% of included studies) aiming to standardise and improve reliability of outcome measures already used in clinical trials, among which two are already published
In the present systematic review, we showed how clinical trials in MS have been leveraging digital technology to improve delivery, adherence and effectiveness of motor rehabilitation and psychotherapy, to standardise collection and interpretation of already existing outcome measures, and to detect MS clinical and treatment features that would otherwise remain invisible in clinical practice, with the development of new outcome measures

Summary

Introduction

Multiple sclerosis (MS) is the most common cause of neurological disability in young adults [1]. MS patients require long-term, multidisciplinary care in both clinical and community settings [5], with the use of disease modifying treatments (DMTs) aiming at reducing the risk of relapses and, at least in part, halting disability progression, along with symptomatic treatments and rehabilitation [2]. Digital technology includes both the delivery of interventions and the collection of data (e.g., outcome measures), using a variety of digital tools, including smartphones, websites, apps, and wearable devices [6,7,8].

Methods

Discussion

Conclusion