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

Ad scientiam

Status: Begins enrollment in 9 months

Conditions: Fatigue Syndrome, Chronic; Multiple Sclerosis

Treatments: Device: MS Boost; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06386133

MS Boost

Details and patient eligibility

About

The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).

The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.

Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.

Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time.

Full description

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged over 18 years
• With a confirmed MS diagnosis according to 2017 McDonald's revised criteria
• Having an EDSS score comprised between 0 and 6.5
• With a fatigue score ≥ 43 on MFIS scale
• Able to walk with or with walking aids
• Owning a personal smartphone with a mobile operating system version higher than 14 for IOS (iPhone) and 8 for Android
• Able to read the language in which the mobile application is available and able to understand pictograms
• Affiliated to a social security system
• Having signed the free and informed consent
• Having accepted to wear an actimeter during the whole duration of study participation
• Having been on a stable disease-modifying therapy for MS for at least 6 months.

Exclusion criteria

• Psychiatric disorder, major visual or cognitive deficiency, as assessed by the investigator
• Participation in an exercise reconditioning program at a rehabilitation center within the 6 weeks prior to inclusion
• Major comorbidities that could influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive pulmonary disease, chronic fatigue syndrome, etc).
• Contraindication to physical activity:
• History of cardiac events:
• Abnormal cardiac examination at last medical check-up.
• Palpitations, tachycardia or irregular heartbeat
• Pain and shortness of breath:
• Cramp-like pain in the lower limbs when walking, disappearing when walking stops, except for MS-related pain (neuropathic or spastic).
• Chest pain
• Shortness of breath at rest (appearing or worsening in the lying position)
• Shortness of breath during low-intensity exercise or usual activities
• Pain, discomfort or heaviness in the chest at rest or during exertion
• Unstable chronic diseases :
• Unstable metabolic disease
• Unstable renal disease
• Uncontrolled chronic disease
• Ankle edema
• Dizziness or syncope
• Having received fampridine, corticosteroid therapy or therapeutic cannabis within the 2 months prior to inclusion.
• Psychoactive substances and/or alcohol consumption likely to influence test performance (investigator's judgment).
• Patients confined to bed or whose daily activity is less than 2 hours.
• Persons under guardianship or curatorship.
• Pregnant or breast-feeding women.
• Subjects who have participated in another clinical study within 30 days prior to selection, or who are participating in another study that, in the opinion of the investigator, could interfere with full participation in the study or confound the participant's assessment or the study results.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Boost Group

Experimental group

Description:

The Boost Group will have the MSCopilot Boost mobile application and follow personalized fatigue management advices and physical activity program

Treatment:

Device: MS Boost

Control Group

Active Comparator group

Description:

The Control Group will follow standard of care with general fatigue advices

Treatment:

Other: Standard of care