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New treatment option for Dyskinetic Cerebral Palsy
Official title Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults
ClinicalTrials.gov ID: NCT06122675
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 25
You may be able to join if
- Diagnosis of DCP (dystonic and/or choreoathetotic cerebral palsy) with or without comorbid spasticity, with a clear history of hypoxic ischemic brain...
- 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...
- Patient and family have requested surgical intervention with DBS for their movement disorder.
You likely can't join if
- Coagulopathy, uncontrolled epilepsy, severe cardiopulmonary or gastrointestinal conditions, or other medical conditions considered to place the...
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.