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

NCT06386133 | Not Yet Recruiting

• 1 other identifier: MS Boost
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis; Fatigue Syndrome, Chronic

Keywords

Mobile application; Digital monitoring; Fatigue management; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis

  Comparison of mean decrease in the Modified Fatigue Impact Scale score (MFIS) between Boost and Control groups from Day 0 to Day 270 . The criteria will be considered as positive if the Boost group shows a mean decrease of at least a 7 point in Day 270 score, compared to the Control group. The score ranges from 0 to 84, with a higher score indicating a worse outcome.

  During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)

Secondary Outcomes (39)

• To evaluate the impact of fatigue in both groups.

  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)

  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.

  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.

  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.

  During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)

Other Outcomes (9)

• To evaluate the link between MSCopilot Boost use compliance and fatigue improvement.

  Throughout the study for all visits in-clinic (Day 0, Day 90, Day 180 and Day 270) and at-home visits (Day 1, D 30, Day 60, Day 89, Day 120, Day 150, Day 210 and Day 240)

• To assess the relationship between self-reported and objectively measured physical activity.

  Throughout the study from Day 0 to Day 270

• To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact.

  During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)

Study Arms (2)

Boost Group

EXPERIMENTAL

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

Device: MS Boost

Control Group

ACTIVE COMPARATOR

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

Other: Standard of care

Interventions

MS Boost DEVICE

remote monitoring digital tool based on functional tests (walking, dexterity, vision and cognition). These digital tests may be combined with a fatigue assessment via questionnaires and, if needed, a telerehabilitation program. This program includes an algorithm comprising fatigue management advice and/or physical activity recommendations personalised to the patients, aimed at improving fatigue-related symptoms. The patient can use the telerehabilitation program without supervision

Boost Group

Standard of care OTHER

General fatigue tips are given to patients who suffering from chronic fatigue such as stop smoking, eat a healthy diet...

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychiatric disorder, major visual or cognitive deficiency, as assessed by the investigator
• 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

Sponsors & Collaborators

• Ad scientiam: lead
• URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue Syndrome, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dr Mikael Cohen

CONTACT

+33 492 03 79 01; Cohen.m@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration. Control group: Standard practice and wear of an actimeter during the whole study participation duration.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 26, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2024-10