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Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy

This study is testing a treatment called Deep Brain Stimulation (DBS) for children and young adults with dyskinetic or dystonic cerebral palsy. DBS involves implanting a device (Medtronic Percept Primary Cell Neurostimulator) in a part of the brain called the cerebellum to deliver electrical stimulation. The goal is to see if this stimulation can safely help with movement problems. Researchers will measure changes in movement using a scale called the Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) and how it affects daily life using the Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD). They are looking for 10 participants between 7 and 25 years old who have cerebral palsy due to a specific type of brain injury. The current recruitment status is unclear.

Study design
This is an interventional study involving 10 participants. It includes a randomized blinded phase where participants receive either sham (inactive) stimulation or active stimulation.
What's involved
During the randomized blinded phase, your movement and daily life will be evaluated weekly for a total of 3 months in each condition (sham and active stimulation).
Compensation
Not stated in the trial record.
Follow-up
Your progress will be evaluated weekly during the randomized blinded phase, which lasts for a total of 3 months in each condition (sham and effective stimulation).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06122675

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

Recruiting
NAAges 7–25InterventionalTreatment
University of California, San Francisco
~10 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:DBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average total (global index) Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) scores
Measured over Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).
+1 more outcome measured

Conditions

Dyskinetic Cerebral Palsy
Dystonic Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Marta San Luciano Palenzuela, MD, MS
[email protected]
4153532311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Average total (global index) Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) scoresEvaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

    This is the primary motor outcome measure. It is the Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18 R). The MD-CRS 4-18 R is a validated tool aimed to evaluate movement disorders in developmental age. It is particularly useful for rating the severity of movement disorders in dyskinetic cerebral palsy. It scored based on two parts. Part I: General Assessment has a minimum total score of 0 (no impairment) and a maximum total score of 60 (maximal impairment). Part II: MD Assessment has a minimum total score of 0 (movement disorder is absent) and a maximum total score of 28 (maximal movement disorder presence).

  • Average total standardized Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) scoresEvaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

    This is the primary Quality of Life (QOL) outcome measure. It is the Caregiver Priorities \& Child Health Index of Life with Disabilities (CPCHILD) scale. The CPCHILD is a reliable and valid measure of caregivers' perspectives on health status, functional limitations, and well-being of patients with severe CP, including those individuals who are non-verbal and non-ambulatory. Because many children suffering with CP are severely affected in many areas of their lives including activities of daily living, communication, mobility and overall health, there is an imperative to evaluate new interventions, especially invasive and resource-intensive ones such as DBS, using outcomes that are more meaningful to patients and their caregivers. Scores for each domain and for the total survey are standardized and range from 0 (worst) to 100 (best).