Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care

Multiple sclerosis (MS) is an autoimmune, inflammatory disease of the central nervous system that causes unpredictable neurological symptoms. It is the leading cause of non-traumatic disability in young adults in France. MS often leads to mobility impairments, visual problems (26% of patients), cognitive dysfunction (40-70%) and chronic fatigue, which affects more than 70% of patients. Fatigue, a major problem for 55% of patients, reduces energy, affects work capacity and increases sickness absence. Despite its importance, common clinical tools such as the EDSS and MSFC-4 do not assess fatigue.

MS-related fatigue is multifactorial, influenced by disease phenotype, comorbidities (e.g. depression, pain, sleep problems) and lifestyle factors. Fatigue assessments such as the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) are commonly used, but have validity issues and often require additional qualitative methods.

There is no clear consensus on the management of fatigue in MS. Pharmacological treatments show inconsistent results and non-pharmacological methods, particularly physical activity, are promising. Moderate exercise and resistance training improve symptoms and fitness, but no single exercise regimen is superior, so individualised approaches are needed. Multidisciplinary management combining physical activity, behavioural therapies and sometimes medications is increasingly recommended.

Most people with MS do not meet physical activity guidelines, highlighting the need for tailored exercise programmes. Mobile applications for remote monitoring and self-management offer promising solutions to enable patients to maintain activity and manage symptoms between medical visits.

Ad Scientiam has developed MSCopilot Boost, a medical software device that supports remote monitoring and management of MS symptoms. It includes a smartphone app with functional tests for walking, dexterity, vision, cognition and fatigue, and a telerehabilitation programme with personalised advice. Healthcare professionals can track patient progress via a web portal, making MSCopilot Boost a complementary tool to support consultations, rather than a stand-alone diagnostic device.

The primary objective of the MS Boost study is to demonstrate the efficacy of MSCopilot Boost in reducing the impact of fatigue in people with MS. Secondary objectives include evaluating its performance in reducing fatigue, improving functional testing, ensuring safety, and assessing its impact on symptoms and physical activity levels. The study also aims to measure patient and healthcare professional satisfaction, adherence and user experience with the app and web portal, and to define its organisational and economic impact.

Patients could benefit from additional clinical tests, real-time monitoring of functional parameters and a personalised fatigue management programme, while healthcare professionals would gain insight into patients' conditions over time, enabling more efficient management of MS-related symptoms.

• To evaluate the impact of fatigue in both groups. [Срок оценки: During the first in-clinic visit (Day 0), during the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)]
• To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term) [Срок оценки: During the first in-clinic visit (Day 0) and during the in-clinic follow-up visits (Day 90 and Day180)]
• To compare the fatigue impact between the two groups. [Срок оценки: During the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)]
• To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice. [Срок оценки: During the first in-clinic visit (Day 0), during the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)]
• Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. [Срок оценки: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)]
• Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital. [Срок оценки: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)]
• Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. [Срок оценки: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)]
• Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. [Срок оценки: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)]
• Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. [Срок оценки: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)]
• Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital [Срок оценки: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)]
• Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital [Срок оценки: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)]
• Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital [Срок оценки: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)]