Quantifying Motor Network Dynamics to Predict and Enhance... | NCT07325175

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

NCT07325175

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Dystonia
Pediatric
Deep Brain Stimulation
Motor Development

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Travis Larsh, Assistant Professor, Children's Hospital Medical Center, CincinnatiPrincipal Investigator

Lead Sponsor

Children's Hospital Medical Center, CincinnatiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DBS	Experimental	Patients with DBS will complete neurophysiological recordings with DBS on and off	Device: DBS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DBS	Device	Subjects with DBS will complete protocol with and without active stimulation	DBS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Longitudinal change in Motor Network Aperiodic Activity		-Baseline -Through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center	Recruiting	Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Available upon reasonable request and discussion

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004421	Dystonia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided