Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia

NCT ID: NCT07325175

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dystonia Pediatric Deep Brain Stimulation Motor Development

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DBS

Patients with DBS will complete neurophysiological recordings with DBS on and off

Group Type EXPERIMENTAL

DBS

Intervention Type DEVICE

Subjects with DBS will complete protocol with and without active stimulation

Interventions

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DBS

Subjects with DBS will complete protocol with and without active stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Travis Larsh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Karlee Migneault

Role: primary

513-636-4200

Other Identifiers

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2016-9025

Identifier Type: -

Identifier Source: org_study_id

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