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Procedure

Deep Brain Stimulation for Cerebral Palsy

Phase 1 & 2

Recruiting

Led By Marta San Luciano Palenzuela, MD, MS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gross Motor Function Classification System (GMFCS) Levels II-V

Age 7-25 at the time of surgery

Must not have

Severe fixed contractions and skeletal deformities that would preclude determination of improvement

Requirement of diathermy, electroconvulsive therapy or transcranial magnetic stimulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

Summary

"This trial aims to test the safety of using Deep Brain Stimulators in the cerebellum to treat movement symptoms in individuals with dyskinetic cerebral palsy. Ten participants will receive a Medtronic

Who is the study for?

This trial is for children and young adults aged 7-25 with dyskinetic cerebral palsy (DCP), who have tried oral medications without enough relief. They should be able to attend follow-up visits, have a history of brain injury before their motor symptoms started, and not have major cerebellar abnormalities on an MRI.

What is being tested?

The study tests the safety of Deep Brain Stimulation (DBS) in the cerebellum using Medtronic Percept Neurostimulators to treat movement disorders caused by cerebral palsy. It includes videotaped movement analysis, gait analysis, and monitoring physiological and neuroimaging markers.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risk from surgery, headache or dizziness post-operation, possible changes in mood or behavior due to electrical stimulation, and unintended impacts on muscle movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My mobility is moderately to severely limited.

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I am between 7 and 25 years old and need surgery.

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I have given my written consent, and if under 18, I also provided verbal assent.

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I have cerebral palsy with movement issues, confirmed by a brain scan and a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe joint stiffness or bone deformities that would not show improvement.

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I need treatments like diathermy, electroconvulsive therapy, or magnetic stimulation.

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I have had a traumatic brain injury or encephalitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation).

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Effective stimulationActive Control1 Intervention

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.

Group II: Sham stimulationPlacebo Group1 Intervention

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

0 / 7Eligibility criteria met