75 Participants Needed

Deep Brain Stimulation for Pediatric Dystonia

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to understand the development and progression of childhood dystonia, a movement disorder, in children. The main questions it aims to answer are:

How does the activity of the neural network evolve in children with dystonia in the context of motor development? What are the effects of chronic and active stimulation on cortical and subcortical motor network function in children with deep brain stimulation (DBS)?

Participants will:

* Undergo noninvasive electrophysiological measurements (EEG, EMG) to quantify neural network activity. They will be tested at rest and during a simple motor reaction task.

* Children with DBS will be assessed in the on and off DBS state to assess effects of chronic and active changes in motor network function.

Are You a Good Fit for This Trial?

This trial is for children with dystonia, a movement disorder. They should be able to complete study tasks and have normal development milestones without any neuropsychiatric disorders or significant medical conditions.

Inclusion Criteria

My child has reached all their developmental milestones on time.
I do not have any mental health disorders.
I have been diagnosed with dystonia, with or without deep brain stimulation.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo noninvasive electrophysiological measurements (EEG, EMG) to quantify neural network activity at rest and during a simple motor reaction task

1-2 weeks
1 visit (in-person)

DBS Assessment

Children with DBS are assessed in the on and off DBS state to evaluate effects of chronic and active changes in motor network function

1-2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation

Trial Overview

The study examines how neural networks in the brain change during motor development in kids with dystonia and measures the impact of Deep Brain Stimulation (DBS) on these networks through noninvasive tests like EEG and EMG.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+