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PREDICT-ITB: Predicting response in children with dystonic CP to ITB - study protocol.

Sruthi P Thomas, Darcy Fehlings, Sharon Ramey

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    Summary

    This study investigates intrathecal baclofen (ITB) for children with cerebral palsy (CP) and dystonia, assessing its impact on motor function, pain, and quality of life. Findings aim to identify treatment responders and improve care for pediatric CP patients.

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    Area of Science:

    • Neurology
    • Pediatrics
    • Rehabilitation Medicine

    Background:

    • Cerebral palsy (CP) affects over 11,000 infants annually, with significant lifetime costs.
    • Elevated muscle tone (dystonia, spasticity) in CP severely impacts function and quality of life.
    • Intrathecal baclofen (ITB) is used for dystonic CP, but its effectiveness is debated due to study limitations and patient variability.

    Purpose of the Study:

    • To evaluate the overall impact of ITB on children with dystonic CP.
    • To identify patient subgroups who respond best to ITB therapy.
    • To develop a comprehensive outcome measure for ITB treatment in pediatric dystonic CP.

    Main Methods:

    • A prospective, observational study of 65 children with dystonia (Barry Albright Dystonia Scale > 15) and CP receiving ITB.
    • Assessment of changes in dystonia, spasticity, motor function, and patient-reported outcomes at 3, 6, and 12 months.
    • Primary analysis using repeated measures models; secondary analyses for other outcomes and subgroup identification.

    Main Results:

    • (Study ongoing - results to be published)

    Conclusions:

    • (Study ongoing - conclusions to be published)