Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DBS.
- Who it may be relevant to
- Registry conditions: Dyskinetic Cerebral Palsy, Dystonic Cerebral Palsy. Basic parameters: 7 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults With Cerebral Palsy
Overview
The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat movement symptoms related to cerebral palsy. Ten children and young adults with dyskinetic cerebral palsy will be implanted with a Medtronic Percept Primary Cell Neurostimulator. We will pilot videotaped automated movement recognition techniques and formal gait analysis, as well as collect and characterize each subject's physiological and neuroimaging markers that may predict hyperkinetic pathological states and their response to therapeutic DBS.
Interventions
- Device DBS
Implanted in the cerebellum.
Primary outcome measures
- Average total (global index) Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) scores [Time frame: Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).]
- Average total standardized Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) scores [Time frame: Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- San Luciano M, Oehrn CR, Wang SS, Tolmie JS, Wiltshire A, Graff RE, Zhu J, Starr PA. Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy. BMC Neurol. 2024 Apr 29;24(1):145. doi: 10.1186/s12883-024-03633-z. PMID 38684956
- San Luciano M, Oehrn CR, Wang SS, Tolmie JS, Wiltshire A, Graff RE, Zhu J, Starr PA. Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy. Res Sq [Preprint]. 2024 Apr 1:rs.3.rs-4077387. doi: 10.21203/rs.3.rs-4077387/v1. PMID 38645256
Identifiers
NCT: NCT06122675 · 22-37182 · UH3NS128297-01A1