Actively Recruiting

Phase Not Applicable
Age: 7Years - 25Years
All Genders
NCT06122675

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

Led by University of California, San Francisco · Updated on 2025-03-27

10

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 7Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of dystonic and/or choreoathetotic cerebral palsy with or without spasticity confirmed by a pediatric neurologist and supported by MRI findings
  • Age between 7 and 25 years at the time of surgery
  • Gross Motor Function Classification System levels II to V
  • History of treatment with oral medications with inadequate symptom relief as determined by a specialist
  • Patient and family have requested DBS surgery for movement disorder
  • No major cerebellar abnormalities on structural MRI
  • Written informed consent and assent (verbal or written) for participants under 18 years
  • Ability to comply with study follow-up visits for brain recordings, neuroimaging, sham and effective stimulation testing, and clinical assessments
Not Eligible

You will not qualify if you...

  • Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions that increase surgical risk
  • Pregnancy or positive pregnancy test before surgery for women of child-bearing potential
  • Presence of genetic conditions mimicking cerebral palsy without documented brain injury or congenital malformation
  • Severe fixed muscle contractions or skeletal deformities preventing assessment of improvement
  • History of traumatic brain injury, infectious or autoimmune encephalitis
  • Requirement for diathermy, electroconvulsive therapy, or transcranial magnetic stimulation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

M

Marta San Luciano Palenzuela, MD, MS

CONTACT

S

Sarah Wang, PhD, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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