Recruiting

Dystonia Assessment

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07325175

Conditions

Dystonia

Pediatric

Deep Brain Stimulation

Motor Development

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Accepted

Interventions

DBS

Study Details

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

Dystonia

Pediatric

Deep Brain Stimulation

Motor Development

Study ID

NCT07325175

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: DBS

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

Interventions

DBS

Subjects with DBS will complete protocol with and without active stimulation

Primary outcome measure

  • Longitudinal change in Motor Network Aperiodic Activity [ Time Frame: -Baseline -Through study completion, an average of 2 years ]

Central Contacts and Locations

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Karlee Migneault

513-636-4200karlee.migneault@cchmc.org

Principal Investigator:

Travis Larsh, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-08-27.