Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585618
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
A Multicenter Pediatric Deep Brain Stimulation Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Pediatric Deep Brain Stimulation Registry
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBS-R
Brief Summary:
There is limited data on outcomes for children who have undergone deep brain stimulation DBS for movement disorders and individual centers performing this surgery often lack sufficient cases to power research studies adequately This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data The primary goals are to enable large-scale well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders Given the current scarcity of evidence available to clinicians this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None