Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DBS.
- Who it may be relevant to
- Registry conditions: Dystonia, Pediatric, Deep Brain Stimulation, Motor Development. Basic parameters: 6 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device DBS
Subjects with DBS will complete protocol with and without active stimulation
Primary outcome measures
- Longitudinal change in Motor Network Aperiodic Activity [Time frame: -Baseline -Through study completion, an average of 2 years]
Secondary outcome measures (2)
- Longitudinal change in Motor Network Periodic Activity [Time frame: -Baseline -Through study completion, an average of 2 years]
- Longitudinal change in Motor Network EEG connectivity [Time frame: -Baseline -Through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
- For dystonia subjects:
- Dx of dystonia (with and without DBS)
- willingness and ability to complete study protocols.
- For Typically Developing Controls:
- normal developmental milestones
- absence of any neuropsychiatric disorder
- no significant medical condition.
Exclusion criteria
- history of epilepsy
- presence of implanted medical devices (except DBS in dystonia subjects)
- lack of cognitive or physical ability to complete study protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT07325175 · 2016-9025