Multiple SclerosisMSBoostNCT06386133
Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care
A study testing MS Boost in people with Multiple Sclerosis and Fatigue Syndrome, Chronic, run by Ad scientiam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Fatigue Syndrome, Chronic
- What is being tested?
- MS Boost
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care
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.
Read more
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Fatigue Syndrome, Chronic
- Being tested
- MS Boost, Standard of care
- Keywords
- Mobile application, Digital monitoring, Fatigue management, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS BoostDevice
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
Standard of careOther
General fatigue tips are given to patients who suffering from chronic fatigue such as stop smoking, eat a healthy diet...
| Study group | Role | What they receive |
|---|---|---|
| Boost Group | Experimental | The Boost Group will have the MSCopilot Boost mobile application and follow personalized fatigue management advices and physical activity program Receives: Device: MS Boost |
| Control Group | Active comparator | The Control Group will follow standard of care with general fatigue advices Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measure of the mean decrease in Modified Fatigue Impact Scale score:
- In the Boost group
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
- In the Control group
- Between Day 0 and Day 90
- Between Day 0 and Day180
- Between Day 0 and Day 270
The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Measured: 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)
Comparison of the mean decrease in Modified Fatigue Impact Scale score:
- Between Day 0 and Day 90
- Between Day 0 and Day 180
The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Measured: 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.
Comparison of Modified Fatigue Impact Scale score between the two groups:
- At Day 90
- At Day 180
- At Day 270
The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Measured: 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.
Comparison of the mean fatigue score by using a visual analog scale (from daily activities impact questionnaire) between the two groups:
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
Score ranges from 0 (not impacted) to 10 (very impacted), with a higher score indicating a worse outcome.
Measured: 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.
Pearson correlation coefficient to evaluate the correlation between the active Mobile Walking Perimeter Test (in meter) performed at Day 1 (at home) with the standard test Timed 25 Foot Walk (in seconds) performed at Day 0 (at the hospital) in the Boost group.
Measured: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital.
Pearson correlation coefficient to evaluate the correlation between the active Mobile Walking Endurance Test (in meters) performed at Day 1 (at home) with the standard test Timed 25 Foot Walk (in seconds) performed at Day 0 (at the hospital) in the Boost group.
Measured: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Pearson correlation coefficient to evaluate the correlation between the active Mobile Dexterity Test (in seconds) performed at Day 1 (at home) with the standard test 9 Hole Peg Test (in seconds) performed at Day 0 (at the hospital) in the Boost group.
Measured: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Pearson correlation coefficient to evaluate the correlation between the active Mobile Cognition Test (score) performed at Day 1 (at home) with the standard Symbol Digit Modalities Test (score) performed at Day 0 (at the hospital) in the Boost group.
Measured: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Pearson correlation coefficient to evaluate the correlation between the active Mobile Vision Test (number stated) performed at Day 1 (at home) with the standard Sloan Low Contrast Letter Acuity Test (number of letter stated) performed at Day 0 (at the hospital) in the Boost group.
Higher is the number of letter or number stated, better is the outcome.
Measured: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Daily activities impact questionnaire completed by patients at Day 0 and Day 270.
The score ranges from 0 to 10, with higher score meaning worse outcome.
Measured: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Modified Fatigue Impact Scale-5 questionnaire completed by patients at Day 0 and Day 270.
Score ranges from 0 to 20, with higher score meaning worse outcome.
Measured: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Sleep questionnaire completed by patients at Day 0 and Day 270.
Measured: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Mental well-being (PHQ-4) questionnaire completed by patients at Day 0 and Day 270.
Score ranges from 0 to 12, with higher score meaning worse outcome.
Measured: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Physical Activity Level questionnaire (IPAQ) completed by patients at Day 0 and Day 270.
Measured: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Intraclass correlation coefficient (ICC) to assess the reproducibility between the Mobile Walking Perimeter Test (in meters) performed at hospital and at home
- At Day 0 and Day 1
- At Day 89 and Day 90
Higher is the distance, better is the outcome.
Measured: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Intraclass correlation coefficient (ICC) to assess the reproducibility between the Mobile Dexterity Test (in seconds) performed at hospital and at home
- At Day 0 and Day 1
- At Day 89 and Day 90
Shorter is the time, better is the outcome.
Measured: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Intraclass correlation coefficient (ICC) to assess the reproducibility between the Mobile Cognition Test performed at hospital and at home
- At Day 0 and Day 1
- At Day 89 and Day 90
Higher is the score, better is the outcome.
Measured: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Intraclass correlation coefficient (ICC) to assess the reproducibility between the Mobile Vision Test performed at hospital and at home
- At Day 0 and Day 1
- At Day 89 and Day 90
Higher is the number or letter stated, better is the outcome.
Measured: 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)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile walking perimeter test (in meter) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.
Higher is the distance, better is the outcome.
Measured: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile Dexterity Test (in seconds) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.
Shorter is the time, better is the outcome.
Measured: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile cognition Test (score) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.
Higher is the score, better is the outcome.
Measured: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile vision test (number of letter stated) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.
Higher is the number or letter stated, better is the outcome.
Measured: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile Walking Endurance test (in meters) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.
Higher is the distance, better is the outcome.
Measured: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To assess the number of adverse events of using MSCopilot Boost.
The application's safety of use will be assessed through a descriptive analysis of adverse events and Adverse Events associated with its use. Data relative to Adverse Events will be reported on a table, numbers and percentages reported for each group, categorizing Adverse Events as mild, moderate and severe. A descriptive analysis of risk questionnaire responses in the Boost group will also be performed.
Measured: 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 compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home
Comparison of mean improvement in results between the two groups:
- For the Timed 25 Foot Walk test (in seconds)
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
- Measured by actimeter:
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
Shorter is the time, better is the outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Fatigue impact.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Modified Fatigue Impact Scale (MFIS)
The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on anxiety and depression.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Patient Health Questionnaire-4 (PHQ-4)
Score ranges from 0 to 12, with higher score indicating worse outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Depression.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Beck Depression Inventory - Fast Screen (BDI- FS).
The score ranges from 0 to 21, with higher score indicating worse outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Fatigue.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on Fatigue with visual analog scale (from daily activities impact questionnaire)
The score ranges from 0 to 10, with higher score indicating worse outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Walking.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Timed 25 Foot Walk test (in seconds).
Shorter is the time, better is the outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Dexterity.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the 9 Hole Peg Test (in seconds).
Shorter time indicating better outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on Cognition.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Symbol Digit Modalities Test.
Higher is the score, better is the outcome.
Measured: 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 proportion of patients whose symptoms improved in both groups on the Low-contrast Vision.
Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Sloan Low Contrast Letter Acuity Test (number stated).
Higher is the number or letter stated, better is the outcome.
Measured: 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 on quality of life compared to standard practice.
Comparison of mean improvement in EQ5D-5L results between the two groups:
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
The scale ranges from 0 to 100, with higher score means better outcome.
Measured: 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 on the mean overall physical activity compared to standard practice.
Comparison of the evolution of the mean overall physical activity in Metabolic Equivalent of Task (MET) measured by actimeter between the two groups:
- Between Day 0 and Day 90
- Between Day 0 and Day 180
- Between Day 0 and Day 270
Measured: 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 evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost.
Descriptive analysis of responses collected from satisfaction and user experience questionnaires in the Boost group and from healthcare professionals.
Each answer propose a scale from 1 to 5 or 1 to 10. Higher score means better outcome.
Measured: During at-home follow-up visit (Day 30) and in-clinic visits (Day 180 and Day 270)
To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals.
Descriptive analysis of collected responses from clinical benefit questionnaires in Boost group and from healthcare professionals.
Each answer propose a scale form 1 to 10 with higher score means better outcome.
Measured: During the end of study visit in-clinic (Day 270)
To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals.
Descriptive analysis of collected responses from organizational impact questionnaire administered to healthcare professionals.
Each answer propose 5 levels of intensity from totally disagree to totally agree.
Measured: During the end of study visit in-clinic (Day 270)
To assess user compliance with MSCopilot Boost throughout the follow-up period.
Number of completed evaluations per quarter compared to the theoretical maximum completion expected over time in the Boost group:
- Functional tests
- Fatigue evaluation questionnaires
- Fatigue management program (tips and physical activity program)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Collaborators
- URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386133
- Sponsor's protocol ID
- MS Boost
- Acronym
- MSBoost
- Status last verified
- Oct 2024
- First submitted
- 16 Apr 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care
- ClinicalTrials.gov ID
- NCT06386133
- Acronym / sponsor ID
- MSBoost / MS Boost
- Conditions
- Multiple Sclerosis, Fatigue Syndrome, Chronic
- Keywords
- Mobile application, Digital monitoring, Fatigue management, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Collaborators
- URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Boost Group | Experimental | Device: MS BoostThe Boost Group will have the MSCopilot Boost mobile application and follow personalized fatigue management advices and physical activity program |
| Control Group | Active comparator | Other: Standard of careThe Control Group will follow standard of care with general fatigue advices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS Boostremote 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 | Device | Boost Group |
| Standard of careGeneral fatigue tips are given to patients who suffering from chronic fatigue such as stop smoking, eat a healthy diet... | Other | Control Group |
Primary outcome
To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
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.
39 secondary outcomes
To evaluate the impact of fatigue in both groups.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital.
Time frame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Time frame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Time frame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
Time frame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
Time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Time frame: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Time frame: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Time frame: 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)
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
Time frame: 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)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Time frame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Time frame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
Time frame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
Time frame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
Time frame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
To assess the number of adverse events of using MSCopilot Boost.
Time frame: 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 compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home
Time frame: 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 proportion of patients whose symptoms improved in both groups on Fatigue impact.
Time frame: 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 proportion of patients whose symptoms improved in both groups on anxiety and depression.
Time frame: 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 proportion of patients whose symptoms improved in both groups on Depression.
Time frame: 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 proportion of patients whose symptoms improved in both groups on Fatigue.
Time frame: 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 proportion of patients whose symptoms improved in both groups on Walking.
Time frame: 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 proportion of patients whose symptoms improved in both groups on Dexterity.
Time frame: 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 proportion of patients whose symptoms improved in both groups on Cognition.
Time frame: 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 proportion of patients whose symptoms improved in both groups on the Low-contrast Vision.
Time frame: 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 on quality of life compared to standard practice.
Time frame: 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 on the mean overall physical activity compared to standard practice.
Time frame: 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 evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost.
Time frame: During at-home follow-up visit (Day 30) and in-clinic visits (Day 180 and Day 270)
To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals.
Time frame: During the end of study visit in-clinic (Day 270)
To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals.
Time frame: During the end of study visit in-clinic (Day 270)
To assess user compliance with MSCopilot Boost throughout the follow-up period.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MS Boost in people with Multiple Sclerosis and Fatigue Syndrome, Chronic, run by Ad scientiam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Mikael Cohen (+33 492 03 79 01, Cohen.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (time frame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.