MedTrace Logo

Predictive Factors for Succes of ITB in CP

NCT05817409 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2023-04-18

No results posted yet for this study

Summary

For children with severe cerebral palsy (CP) in whom other options are insufficient, intrathecal baclofen (ITB) treatment could be an option. Literature provides some evidence for the effect of ITB, however we notice that not all children benefit equally. Furthermore long term effects of ITB in a prospective cohort of individuals with CP have not yet been described in literature. To improve selection for ITB physicians need to know which factors influence outcome on the long term. In order to accomplish these goals prospectively, real life data over a long period of time, and from a large cohort are needed.

The investigators will therefore conduct a prospective observational cohort study using the Netherlands CP register to collect data over a period of 4,5 years. The Netherlands CP register is an innovative register for data collection which was developed between 2016 and 2020 in a unique collaboration between children with CP, their parents, researchers and health care professionals.

All children and adolescents with CP, who start ITB treatment in the Netherlands under the age of 16, diagnosed with spastic or dyskinetic CP, are eligible for inclusion in the study.

The primary outcome measure is goal attainment scaling (GAS) in which achievement of individual goals can be quantified. Factors that potentially influence outcome including spasticity, dystonia, scoliosis and complications will be secondary outcome measures.

Measurements will be done before initiation of ITB, after 3 months, after 1 year and after 2 years.

Statistical analysis will include effect size Cohen's d for all outcome measures. To assess which factors are possibly associated with GAS T-score outcome at follow-up multiple regression analysis will be conducted.

Conditions

  • Cerebral Palsy
  • Intrathecal Baclofen

Interventions

DRUG

Intrathecal Baclofen Pump

intrathecal baclofen treatment

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Annemieke Buizer, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817409 on ClinicalTrials.gov