Brain pacemaker for kids with cerebral palsy? new trial tests safety

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of DCP (dystonic and/or choreoathetotic cerebral palsy) with or without comorbid spasticity, with a clear history of hypoxic ischemic brain injury preceding motor symptoms made by a pediatric neurologist, with supporting MRI findings. * Age 7-25 at the time of surgery. * Gross Motor Function Classification System (GMFCS) Levels II-V. * History of appropriate therapy with oral medications with inadequate relief as determined by a movement disorders or pediatric neurologist. Prior history of selective dorsal rhizotomy is allowed. * Patient and family have requested surgical intervention with DBS for their movement disorder. * No gross cerebellar abnormalities observed and reported on structural MRI. * Written informed consent and written/verbal assent for those younger than 18 years of age. * Ability to comply with study follow-up visits for brain recordings, neuroimaging and testing of sham and effective stimulation and clinical assessments. Exclusion Criteria: * Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions considered to place the patient at elevated risk for surgical complications. * Pregnancy: all women of child-bearing potential will be required to have a negative urine pregnancy test prior to undergoing their surgical procedure. * Exclusion of genetic mimics of cerebral palsy: exclusion of conditions that manifest with a clinical syndrome similar to CP, in the absence of documented risk factors or neuroimaging findings consistent with a history of brain injury or congenital cerebral malformation. Work up may include comparative genomic hybridization (CGH) microarray and multi-gene panel and/or whole genome or whole exome sequencing.) * Severe fixed contractions and skeletal deformities that would preclude determination of improvement. * Traumatic brain injury (i.e., non-accidental trauma) or history of infectious or autoimmune encephalitis. * Requirement of diathermy, electroconvulsive therapy or transcranial magnetic stimulation.