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

NCT07325175 | Recruiting FDA Device

• 1 other identifier: 2016-9025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Brain Stimulation; Dystonia; Pediatric; Motor Development

Outcome Measures

Primary Outcomes (1)

• Longitudinal change in Motor Network Aperiodic Activity

  -Baseline -Through study completion, an average of 2 years

Secondary Outcomes (2)

• Longitudinal change in Motor Network Periodic Activity

  -Baseline -Through study completion, an average of 2 years

• Longitudinal change in Motor Network EEG connectivity

  -Baseline -Through study completion, an average of 2 years

Study Arms (1)

DBS

EXPERIMENTAL

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

Device: DBS

Interventions

DBS DEVICE

Subjects with DBS will complete protocol with and without active stimulation

DBS

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• history of epilepsy
• presence of implanted medical devices (except DBS in dystonia subjects)
• lack of cognitive or physical ability to complete study protocol.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)