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Two surgeries, one goal: easing crippling muscle tightness in kids

NCT ID NCT07817745

Symptom relief Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Children and teens with spastic or dystonic quadriplegia from cerebral palsy often need surgery to control severe muscle tightness that interferes with comfort, movement, and care. Doctors at Boston Children's Hospital are tracking outcomes for two approaches: implanted baclofen pumps that deliver medicine around the clock, and a one-time combined dorsal/ventral rhizotomy that cuts specific nerve fibers without leaving hardware behind. The study follows about 100 patients before and after surgery, measuring muscle tightness, dystonia, quality of life, and complications to learn which children benefit most from each option.

What this could mean

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

Active substance
Two surgical approaches for muscle tone: an implanted baclofen pump that delivers medicine continuously, and a one-time combined dorsal/ventral rhizotomy that cuts specific nerve fibers
What this could lead to
If one approach proves better, doctors could choose the right tone surgery for each child and give families clearer expectations about comfort, movement, and daily care.
What could go wrong
This is a single-center observational study, not a randomized comparison, so differences between the two surgeries may reflect which patients were chosen for each rather than the procedures themselves. Surgery carries risks including infection, bleeding, and changes in sensation or strength.

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 100 people

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

Started

Jun 2024

Expected to finish

Jan 2031

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

Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.

Ages

6 to 25 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: * Any patients undergoing intrathecal baclofen pump insertion or combined dorsal ventral rhizotomy at Boston Children's Hospital. * Must be at least 6 years of age at time of enrollment Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

cerebral palsy Muscle Spasticity spastic quadriplegic cerebral palsy

As listed by the trial registrant

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

Cerebral palsy (CP) Spastic/dystonic quadriplegia

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

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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