A Multicenter Pediatric Deep Brain Stimulation Registry
NCT ID: NCT06585618
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-07-30
2029-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
0 Years
18 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Darius Ebrahimi-Fakhari
Principal Investigator
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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IRB-P00047069
Identifier Type: -
Identifier Source: org_study_id
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