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A Multicenter Pediatric Deep Brain Stimulation Registry

NCT06585618 · Boston Children's Hospital
In plain English

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Official title
Multicenter Pediatric Deep Brain Stimulation Registry
About this study
The use of deep brain stimulation (DBS) has expanded to include multiple conditions in children including dystonia, epilepsy, Tourette syndrome and mood disorders. Despite its growing application, DBS remains a low-volume procedure in most pediatric centers, which limits opportunities for large-scale research studies. To overcome this challenge, an international data-sharing platform is essential for advancing knowledge about DBS in pediatric patients, particularly concerning surgical techniques and patient outcomes across various conditions. This study aims to establish a multicenter pediatric DBS registry. With limited data on pediatric DBS outcomes and a small number of cases at individual centers, there is a need for a comprehensive registry to enable large-scale, well-powered analyses of DBS safety and effectiveness. The primary goals of this study are to: * Establish and implement a multi-center pediatric DBS registry * Facilitate large-scale analyses of DBS safety and effectiveness in children * Refine DBS as a treatment option for dystonia and other hyperkinetic movement disorders in children. Secondary objectives include: * Identifying which patients benefit most from DBS * Determining clinical variables that influence DBS responsiveness * Identifying optimal implant sites for specific conditions * Understanding the long-term effects of DBS in children * Assessing the impact of DBS on the quality of life in pediatric patients The study will involve both prospective and retrospective data collection from pediatric DBS patients.
Eligibility criteria
Inclusion Criteria: * Female or male patients between ages of 0-18 years. * Having received or scheduled to receive DBS for any neurological movement disorder. * Parents or legal guardians are able to provide written consent for prospective enrollment.
Study design
Enrollment target: 100 participants
Age groups: child, adult
Timeline
Starts: 2024-07-30
Estimated completion: 2029-07-30
Last updated: 2026-03-18
Primary outcomes
  • Development of a Multi-Center Pediatric DBS Registry (5 years)
Sponsor
Boston Children's Hospital · other
Contacts & investigators
ContactDarius Ebrahimi-Fakhari, MD, PhD · contact · movementdisorders@children.harvard.edu · 617-355-0097
ContactKathryn Yang, MBChB, FRCPC · contact · movementdisorders@children.harvard.edu
All locations (1)
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
A Multicenter Pediatric Deep Brain Stimulation Registry · TrialPath