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Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults | Clinical Trials | Clareo Health

RECRUITINGNA

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

Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults with Cerebral Palsy

NCT06122675•University of California, San Francisco

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

7 - 25 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

March 26, 2024

Primary Completion Date

January 1, 2029

Completion Date

March 31, 2029

Last Updated

March 27, 2025

Enrollment

ESTIMATED participants

Conditions

Dyskinetic Cerebral PalsyDystonic Cerebral Palsy

Interventions

DBS

DEVICE

Contacts

Marta San Luciano Palenzuela, MD, MS

CONTACT

4153532311 Marta.SanLucianoPalenzuela@ucsf.edu

Sarah Wang, PhD, CCRP

CONTACT

4153537885 Sarah.Wang@ucsf.edu

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

Enhancing Sensorimotor Processing in Children With Dystonia

Dopamine Treatment in Children With Cerebral Palsy With Dystonia- A Double Blind Controlled Study