Multicenter Pediatric Deep Brain Stimulation Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development of a Multi-Center Pediatric DBS Registry
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Development of a Multi-Center Pediatric DBS Registry
时间窗: 5 years
This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy.
次要结局
- Data Collection(5 years)
研究者
Darius Ebrahimi-Fakhari
Principal Investigator
Boston Children's Hospital