An observational study in Dystonia, Epilepsy in Children and Cerebral Palsy, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Boston Children's Hospital · Observational
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.
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:
Secondary objectives include:
The study will involve both prospective and retrospective data collection from pediatric DBS patients.
213 studies on the registry are indexed under Dystonia; 54 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 90 observational studies indexed under Dystonia.
Browse Dystonia studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of both female and male patients aged 0 to 18 years who have either received or are scheduled to receive deep brain stimulation (DBS) for any neurological disorder. Eligibility requires that parents or legal guardians are able to provide written consent for prospective enrollment.
Inclusion Criteria:
Development of a Multi-Center Pediatric DBS Registry
This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy.
Time frame: 5 years
Data Collection
Secondary objectives will focus on using the data collected to answer important research questions such as : 1. Which patients benefit from DBS? 2. Which clinical variables contribute to the responsiveness or nonresponsivness to DBS? 3. Which implant sites are preferred? 4. What are the long-term effects of DBS in the pediatric population? 5. How does DBS affect quality of life in pediatric patients?
Time frame: 5 years
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