Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults with Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Marta San Luciano Palenzuela, MD, MS
Marta.SanLucianoPalenzuela@ucsf.edu
4153532311
Backup
Sarah Wang, PhD, CCRP
Sarah.Wang@ucsf.edu
4153537885
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 10
Treatments
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.
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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