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RecruitingNCT06122675Updated Jun 5, 2026

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

An interventional study of DBS in Dyskinetic Cerebral Palsy and Dystonic Cerebral Palsy, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 7 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
7 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyskinetic Cerebral Palsy
  • Dystonic Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 10 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
10 participants (estimated)

Study 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.

    Device: DBS

  • Sham comparator
    Sham stimulation

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

    Device: DBS

Interventions

  • DeviceDBS

    Implanted in the cerebellum.

    Also known as: Medtronic Percept

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What researchers measure

Primary outcomes

  1. Average total (global index) Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) scores

    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).

    Time frame: Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

  2. Average total standardized Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) scores

    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).

    Time frame: Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

07

Study locations

1 of 1 sites recruiting
  • University of California, San Francisco
    San Francisco, California 94158, United States
    Recruiting
08

References and documents

Publications

  • San Luciano M, Oehrn CR, Wang SS, Tolmie JS, Wiltshire A, Graff RE, Zhu J, Starr PA. Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy. BMC Neurol. 2024 Apr 29;24(1):145. doi: 10.1186/s12883-024-03633-z. PubMed 38684956 ↗
  • San Luciano M, Oehrn CR, Wang SS, Tolmie JS, Wiltshire A, Graff RE, Zhu J, Starr PA. Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy. Res Sq [Preprint]. 2024 Apr 1:rs.3.rs-4077387. doi: 10.21203/rs.3.rs-4077387/v1. PubMed 38645256 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06122675
Lead sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Marta San Luciano Palenzuela, MD (Associate Professor, Neurology, University of California, San Francisco) — Principal investigator
First posted
Nov 8, 2023
Start date
Mar 26, 2024
Primary completion
Jan 1, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jun 5, 2026

Study contacts

Marta San Luciano Palenzuela, MD, MS
Contact
Marta.SanLucianoPalenzuela@ucsf.edu
4153532311
Sarah Wang, PhD, CCRP
Contact
Sarah.Wang@ucsf.edu
4153537885
Marta San Luciano Palenzuela, MD, MS
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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