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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06386133
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ad scientiam
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Fatigue Syndrome, Chronic
Arms & Interventions

Arms

Experimental: Boost Group

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

Active Comparator: Control Group

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

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...

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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