- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325175
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Karlee Migneault
- Phone Number: 513-636-4200
- Email: karlee.migneault@cchmc.org
-
Principal Investigator:
- Travis Larsh, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DBS
Patients with DBS will complete neurophysiological recordings with DBS on and off
|
Subjects with DBS will complete protocol with and without active stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Longitudinal change in Motor Network Aperiodic Activity
Time Frame: -Baseline -Through study completion, an average of 2 years
|
-Baseline -Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Longitudinal change in Motor Network Periodic Activity
Time Frame: -Baseline -Through study completion, an average of 2 years
|
-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
|
-Baseline -Through study completion, an average of 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-9025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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