DystoniaNCT07325175
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
A study testing DBS in people with Dystonia and Pediatric, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Pediatric, Deep Brain Stimulation
- What is being tested?
- DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- history of epilepsy
- presence of implanted medical devices (except DBS in dystonia subjects)
- lack of cognitive or physical ability to complete study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Karlee Migneault, 513-636-4200, karlee.migneault@cchmc.org
Travis Larsh, MD
About this study
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)?
Read more
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
- Being tested
- DBS
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
Subjects with DBS will complete protocol with and without active stimulation
| Study group | Role | What they receive |
|---|---|---|
| DBS | Experimental | Patients with DBS will complete neurophysiological recordings with DBS on and off Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in Motor Network Aperiodic Activity
Measured: -Baseline -Through study completion, an average of 2 years
Secondary outcomes (2)
Longitudinal change in Motor Network Periodic Activity
Measured: -Baseline -Through study completion, an average of 2 years
Longitudinal change in Motor Network EEG connectivity
Measured: -Baseline -Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Sep 2026
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Travis Larsh, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325175
- Sponsor's protocol ID
- 2016-9025
- Other IDs
- 1K23NS149280-01
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Available upon reasonable request and discussion
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
- ClinicalTrials.gov ID
- NCT07325175
- Acronym / sponsor ID
- 2016-9025
- Conditions
- Dystonia, Pediatric, Deep Brain Stimulation, Motor Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS | Experimental | Device: DBSPatients with DBS will complete neurophysiological recordings with DBS on and off |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- For dystonia subjects:
- Dx of dystonia (with and without DBS)
- willingness and ability to complete study protocols.
- For Typically Developing Controls:
- normal developmental milestones
Key exclusion criteria (3 listed)
- history of epilepsy
- presence of implanted medical devices (except DBS in dystonia subjects)
- lack of cognitive or physical ability to complete study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBSSubjects with DBS will complete protocol with and without active stimulation | Device | DBS |
Primary outcome
Longitudinal change in Motor Network Aperiodic Activity
Time frame: -Baseline -Through study completion, an average of 2 years
2 secondary outcomes
Longitudinal change in Motor Network Periodic Activity
Time frame: -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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Available upon reasonable request and discussion
Related trials for Dystonia
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Accelerated TMS for Focal Hand Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS in people with Dystonia and Pediatric, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change in Motor Network Aperiodic Activity (time frame: -Baseline -Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.