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

NCT06386133 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

DEVICE

MS Boost

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

OTHER

Standard of care

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

Sponsors & Collaborators

  • URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital

    collaborator UNKNOWN

  • Ad scientiam

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-08-01
Completion
2027-08-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386133 on ClinicalTrials.gov