Deep brain stimulation for movement disorders in children with cerebral palsy
Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults with Cerebral Palsy
This study is testing if deep brain stimulation can help improve movement problems in children and young adults with dyskinetic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 7 Years to 25 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06122675 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of deep brain stimulation (DBS) in the cerebellum to alleviate movement symptoms associated with dyskinetic cerebral palsy in children and young adults. A total of ten participants aged 7 to 25 will receive a Medtronic Percept Primary Cell Neurostimulator implanted in their brains. The study will also utilize automated movement recognition techniques and formal gait analysis, alongside collecting physiological and neuroimaging data to predict responses to DBS treatment. The goal is to assess how well this intervention can improve motor function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 7-25 with a diagnosis of dyskinetic cerebral palsy and inadequate relief from conventional therapies.
Not a fit: Patients with gross cerebellar abnormalities or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function and quality of life for children and young adults with dyskinetic cerebral palsy.
How similar studies have performed: While deep brain stimulation has been explored in various movement disorders, this specific application in children with cerebral palsy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Marta San Luciano Palenzuela, MD, MS — University of California, San Francisco
- Study coordinator: Marta San Luciano Palenzuela, MD, MS
- Email: Marta.SanLucianoPalenzuela@ucsf.edu
- Phone: 4153532311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.