Clinical trial Recruiting at 1 site Observational Ages 6 to 25

Outcomes of tone-management surgery in children with spastic/dystonic quadriplegia

Official title: Outcomes of Neurosurgical Tone Management

Run by Boston Children's Hospital · NCT07817745 · Data updated 2026-11-12

This study tests how well intrathecal baclofen pumps and dorsal/ventral rhizotomy help improve movement, comfort, and daily life for kids with severe CP and high muscle tone.

Quick facts

Study typeObservational
Ages6 Years to 25 Years
SexAll
Enrollment100 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedJune 26, 2024
Main results expectedJuly 1, 2030
Study endsJanuary 1, 2031
Registry record updatedSeptember 14, 2026
Trial IDNCT07817745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children and adolescents aged 6 years or older with spastic or dystonic quadriplegia (GMFCS IV/V) undergoing intrathecal baclofen pump placement or combined dorsal/ventral rhizotomy at Boston Children's Hospital.

Probably not a fit

Patients who do not experience improvement in tone or function after surgery or those for whom neither procedure is suitable may see little or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study at Boston Children's Hospital evaluating outcomes before and after tone-management procedures in children and young people with spastic or dystonic quadriplegia (GMFCS IV/V). Participants undergo either intrathecal baclofen pump insertion or combined dorsal/ventral rhizotomy, with surveys and clinical observations tracking changes in function, comfort, and quality of life over time. The goal is to improve patient selection and counseling by comparing long-term outcomes of these approaches. Data will be collected from patients aged 6 years and older undergoing the procedures at the institution. Results may inform future care strategies for severe tone management in CP.

Why it matters

Potential benefit: If successful, the study could clarify which tone-management approach offers better long-term outcomes and quality of life for children with severe CP.

How similar studies have gone: Prior experience with intrathecal baclofen and rhizotomy suggests potential benefit, but long-term comparative data remain limited, making this study exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
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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Where it's running

  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.