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Wearable sensors track tiny movements in SMA babies on Cutting-Edge therapies

NCT ID NCT04833348

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 35 infants with spinal muscular atrophy (SMA) who are receiving gene therapy or other advanced treatments. Researchers use small wearable motion sensors to measure how well the babies move their arms and legs over two years. The goal is to create a more precise way to track motor function improvements, rather than relying on standard clinical exams alone.

What this could mean

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

What this could lead to
If successful, this could provide a better way to track motor function in infants with SMA, helping doctors assess treatment effects more precisely.
What could go wrong
This is a small, observational study (35 infants) focused on measurement methods, not a treatment trial. It may not lead to immediate clinical changes or apply to all SMA patients.

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

35 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Mar 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

Up to 2 years

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: * Infants of both sexes * Suffering from spinal muscular atrophy (diagnosis by genetic study "homozygous deletion of SMN1") * Followed up by the Necker Neuromuscular Reference Center (GNMH) * Eligible for innovative therapy (gene therapy or pharmacogenetics) * age of onset of the disease \<1 year * no severe respiratory impairment (dependence on ventilatory support for more than 16 hours per day) or bulbar involvement * decision of treatment by a Multidisciplinary Consultation Meeting national of experts * Benefiting from social security scheme * Informed consent signed by holders of parental authority and the investigator Exclusion Criteria: * Non-consent of one of the holders of parental authority * Respiratory instability (dependence on ventilatory support for more than 16 hours per day) or hemodynamics * Contraindication to innovative therapy * History of another disease impacting motor skills (neonatal suffering, etc.)

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Conditions

The condition(s) this trial relates to.

spinal muscular atrophy

As listed by the trial registrant

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

Spinal muscular atrophy

Contacts and locations

Locations

  • Hôpital Necker-Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.