Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
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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