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Botox for CP kids: help or harm? new study investigates muscle changes

NCT ID NCT06991725

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how botulinum toxin (Botox) injections change muscle structure in children with spastic cerebral palsy. Using advanced imaging like MRI and 3D ultrasound, researchers will measure muscle size, fat content, and stiffness in 51 children. The goal is to understand the balance between clinical benefits and potential muscle damage, helping guide future treatment decisions.

What this could mean

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

Active substance
Botulinum neurotoxin (Botox)
What this could lead to
If successful, this could help doctors better understand the trade-offs of using Botox in children with cerebral palsy, potentially leading to safer treatment guidelines.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not change current practice immediately.

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.

Participants

About 51 people

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

Started

Feb 2025

Expected to finish

Dec 2028

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.

Who is studied

Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the University Hospitals Leuven. Typically developing children are recruited through the social (family and friends) and professional (colleagues) network of involved researchers and thesis students, who approach participants through flyers, social media.

Ages

2 to 16 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

\- Children with spastic cerebral palsy Inclusion criteria: * Children (boys/girls) with congenital brain lesion, confirmed with neuro-imaging such as MRI * At high-risk for CP or diagnosed spastic type of CP * (Suspected) Gross Motor Function Classification Scale (GMFCS) Level I-III * Uni or bilateral involvement * Aged between 2-16 years Exclusion criteria: * Presence of dyskinesia or ataxia * Severe co-morbidities (cognitive problems) * BTX treatment in the gastrocnemius in the past 10 months * Previous surgery at the investigated muscles. * Previous orthopedic or neurosurgery * Severe ankle deformities * Weight for height values \>2SD or \<-2SD from mean * Typically developing children Inclusion criteria: • Aged between 2-16 years Exclusion criteria: * History of neurological, orthopedic or muscular problems * Involvement in an elite or high-performance sporting program (Children performing the same sports for \> 5 hours/week will be excluded)

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Conditions

The condition(s) this trial relates to.

cerebral palsy Muscle Spasticity spastic cerebral palsy

As listed by the trial registrant

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

Spastic cerebral palsy (SCP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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