NCT06386133Not yet recruiting
Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care
Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care
Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- First submitted
- 16 Apr 2024
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Ad scientiam
- Diseases
- Multiple sclerosis
- NCT number
- NCT06386133
What you commit to
- Study type: Interventional
- Planned participants: 208
- From 1 Dec 2026 to the primary completion date, 1 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in an exercise reconditioning program at a rehabilitation center within the 6 weeks prior to inclusion
- Having received fampridine, corticosteroid therapy or therapeutic cannabis within the 2 months prior to inclusion.
- 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.
Other illness
- 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).
- History of cardiac events:
- Abnormal cardiac examination at last medical check-up.
- Unstable chronic diseases :
- Unstable metabolic disease
- Unstable renal disease
- Uncontrolled chronic disease
Other
- Contraindication to physical activity:
- 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
- Ankle edema
- Dizziness or syncope
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.