RECRUITING

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

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Conditions

Dyskinetic Cerebral PalsyDystonic Cerebral Palsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06122675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age 7-25 at the time of surgery.
  3. * Gross Motor Function Classification System (GMFCS) Levels II-V.
  4. * 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.
  5. * Patient and family have requested surgical intervention with DBS for their movement disorder.
  6. * No gross cerebellar abnormalities observed and reported on structural MRI.
  7. * Written informed consent and written/verbal assent for those younger than 18 years of age.
  8. * Ability to comply with study follow-up visits for brain recordings, neuroimaging and testing of sham and effective stimulation and clinical assessments.
  1. * Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions considered to place the patient at elevated risk for surgical complications.
  2. * Pregnancy: all women of child-bearing potential will be required to have a negative urine pregnancy test prior to undergoing their surgical procedure.
  3. * 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.)
  4. * Severe fixed contractions and skeletal deformities that would preclude determination of improvement.
  5. * Traumatic brain injury (i.e., non-accidental trauma) or history of infectious or autoimmune encephalitis.
  6. * Requirement of diathermy, electroconvulsive therapy or transcranial magnetic stimulation.

Contacts and Locations

Study Contact

Marta San Luciano Palenzuela, MD, MS
CONTACT
4153532311
Marta.SanLucianoPalenzuela@ucsf.edu
Sarah Wang, PhD, CCRP
CONTACT
4153537885
Sarah.Wang@ucsf.edu

Principal Investigator

Marta San Luciano Palenzuela, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Marta San Luciano Palenzuela, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2029-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Dyskinetic Cerebral Palsy
  • Dystonic Cerebral Palsy