Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial

摘要: Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due dystonic movements. Intrathecal baclofen treatment a potential option for dystonia has become common practice. Despite this widespread adoption, high quality evidence on effects intrathecal activities lacking prospective data are needed judge usefulness indications palsy. primary aim study provide level one clinical participation in patients. Furthermore, we hope identify characteristics that will predict beneficial effect an individual patient. A double blind placebo-controlled multi-center randomized trial performed 30 children with Patients aged between 4 25 years old confirmed diagnosis palsy, Gross Motor Functioning Classification System IV or V, lesions white matter, cortex who eligible included. Group receive three months continuous group B placebo treatment, both via implanted pump. After month period, all follow-up after nine months. outcome measurement life measured Goal Attainment Scaling. Secondary measurements body functions include dystonia, spasticity, pain, comfort sleep-related breathing disorders. Side monitored whether patient influence outcome. results evidence-based use Nederlands Trial Register, NTR3642