Recruiting

Cerebellar Deep Brain Stimulation

Sponsor:

UCLA

Code:

NCT06122675

Conditions

Dyskinetic Cerebral Palsy

Dystonic Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

Interventions

DBS

Study Details

Brief 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.

Conditions

Dyskinetic Cerebral Palsy

Dystonic Cerebral Palsy

Study ID

NCT06122675

Start date

Mar 26, 2024

Status verified date

Jun, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Effective stimulation

All participants will receive deep brain stimulation (DBS) in the cerebellum. For the first 20 weeks, every participant undergoes an open label phase to titrate stimulation and determine optimal stimulation settings. Following that phase, each participant starts three cycles of randomized, paired 8-week exposure periods, each pair including effective stimulation followed by sham stimulation, or vice versa. Effective stimulation will be the optimal stimulation settings determined during the open label phase.

sham comparator: Sham stimulation

Sham stimulation will be settings at low amplitude (0.1mA) known to be ineffective.

Interventions

DBS

Implanted in the cerebellum.

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Central contacts

Marta San Luciano Palenzuela, MD, MS

4153532311Marta.SanLucianoPalenzuela@ucsf.edu

Sarah Wang, PhD, CCRP

4153537885Sarah.Wang@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Marta San Luciano Palenzuela, MD

Marta.SanLucianoPalenzuela@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-05.