Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compa
Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care
What it found
No result yet.
What was tested
Treatment tested
- MS Boost
Compared with
- Standard of care
What it measured
Main measures
To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis
During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Fatigue
Other measures (26)
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)
FatigueTo 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)
FatigueTo 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)
FatigueTo 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)
FatigueCorrelation 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)
Disability progressionWalking and mobilityArm and hand functionThinking and memoryVisionCorrelation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital.
During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Disability progressionWalking and mobilityCorrelation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
FatigueMood and sleepPhysical functionCorrelation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
During the first in-clinic visit (Day 0), the first at-home visit (Day 1), the follow-up visit at-home (Day 89) and the follow-up visit in-clinic (Day 90)
Walking and mobilityArm and hand functionThinking and memoryVisionTo evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
Walking and mobilityArm and hand functionThinking and memoryTo evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
VisionWalking and mobility
Who could take part
MS (type not specified) · 18 and over · EDSS 0 to 6.5
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Dec 2026
Main results due
Aug 2027
Finished
Aug 2027