Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-21
SponsorChildren's Hospital Medical Center, Cincinnati
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Dx of dystonia (with and without DBS)
willingness and ability to complete study protocols.
normal developmental milestones
absence of any neuropsychiatric disorder
Disqualifiers
history of epilepsy
presence of implanted medical devices (except DBS in dystonia subjects)
lack of cognitive or physical ability to complete study protocol.
Trial design
Design model
Single group
Treatments tested in this trial
DBS
DeviceSubjects with DBS will complete protocol with and without active stimulation
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: DBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Longitudinal change in Motor Network Aperiodic Activity
Time frame
-Baseline -Through study completion, an average of 2 yearsSecondary outcomes
1
Longitudinal change in Motor Network Periodic Activity
Time frame
-Baseline -Through study completion, an average of 2 years2
Longitudinal change in Motor Network EEG connectivity
Time frame
-Baseline -Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov