Deep brain stimulation for movement disorders in children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Family-centered physiotherapy for children with dyskinetic cerebral palsy

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• Using focused ultrasound to treat dyskinetic cerebral palsy in young patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.