Clinical trial NCT06585618: A Multicenter Pediatric Deep Brain Stimulation Registry
Official title: Multicenter Pediatric Deep Brain Stimulation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dystonia
Epilepsy in Children
Cerebral Palsy
Tourette Syndrome
Obsessive-Compulsive Disorder
Neurologic Disorder
Movement Disorders in Children
Movement Disorders
Deep Brain Stimulation
Keywords: Deep Brain Stimulation
DBS
movement disorder
movement disorders in children
dystonia
chorea
dyskinesia
epilepsy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Development of a Multi-Center Pediatric DBS Registry
timeFrame: 5 years
Secondary outcomes:
measure: Data Collection
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children&#39;s Hospital
state: Massachusetts
Study officials:
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