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Can a phone app beat standard care for MS fatigue?

NCT ID NCT06386133

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a digital tool called MSCopilot Boost can reduce the impact of fatigue in people with multiple sclerosis better than standard care. The tool includes remote monitoring of walking, dexterity, vision, and cognition, plus a personalized telerehabilitation program. 208 participants will be followed for 9 months to see if fatigue scores improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MSCopilot Boost (a digital tool with remote monitoring and telerehabilitation)
What this could lead to
If it works, this could provide a new way to manage chronic fatigue in multiple sclerosis using a smartphone app and personalized exercise program.
What could go wrong
This is a relatively small study (208 people) testing a digital intervention, not a drug. The results may not apply to all MS patients, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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    Open the record ↗

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