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

January 6, 2026 updated by: Travis Larsh, Children's Hospital Medical Center, Cincinnati

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

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Travis Larsh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon reasonable request and discussion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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