Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for children and young adults with movement problems caused by a type of cerebral palsy known as dyskinetic or dystonic cerebral palsy. The researchers want to see if placing a device called a Deep Brain Stimulator (DBS) in a part of the brain called the cerebellum can help improve these movement issues. The trial will involve ten participants aged 7 to 25 who have not found enough relief from their symptoms through medications. Participants will undergo surgery to have the DBS implanted and will be closely monitored with various tests to see how well the treatment works and to ensure it is safe.

To be eligible for this trial, participants need to have a specific diagnosis of cerebral palsy, a documented history of brain injury, and a need for surgical intervention. They should be able to follow up with the study team for regular check-ups after the surgery. It’s important to note that certain medical conditions, like uncontrolled epilepsy or severe heart and lung issues, may exclude someone from participating. Overall, this trial aims to explore a promising new therapy that could potentially improve the quality of life for those affected by these challenging movement disorders.

Gender

ALL

Eligibility criteria

• 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.