A Multicenter Pediatric Deep Brain Stimulation Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dystonia, Epilepsy in Children, Cerebral Palsy, Tourette Syndrome. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Pediatric Deep Brain Stimulation Registry
Overview
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.
Primary outcome measures
- Development of a Multi-Center Pediatric DBS Registry [Time frame: 5 years]
Secondary outcome measures (1)
- Data Collection [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Publications
- Camfield P, Camfield C. Incidence, prevalence and aetiology of seizures and epilepsy in children. Epileptic Disord. 2015 Jun;17(2):117-23. doi: 10.1684/epd.2015.0736. PMID 25895502
- Zesiewicz TA, Sullivan KL, Hauser RA. Levodopa-induced dyskinesia in Parkinson's disease: epidemiology, etiology, and treatment. Curr Neurol Neurosci Rep. 2007 Jul;7(4):302-10. doi: 10.1007/s11910-007-0046-y. PMID 17618536
- Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3. PMID 19889013
- Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder. Pediatrics. 2012 Feb;129(2):256-64. doi: 10.1542/peds.2010-1371. Epub 2012 Jan 23. PMID 22271699
- Sillanpaa M. Long-term outcome of epilepsy. Epileptic Disord. 2000 Jun;2(2):79-88. PMID 10954238
- Vasconcellos E, Wyllie E, Sullivan S, Stanford L, Bulacio J, Kotagal P, Bingaman W. Mental retardation in pediatric candidates for epilepsy surgery: the role of early seizure onset. Epilepsia. 2001 Feb;42(2):268-74. doi: 10.1046/j.1528-1157.2001.12200.x. PMID 11240601
- Wendorff J. [Epilepsy and mental retardation. The school's functioning in children with epilepsy]. Przegl Lek. 2010;67(11):1175-8. Polish. PMID 21442972
- Thompson R, Kerr M, Glynn M, Linehan C. Caring for a family member with intellectual disability and epilepsy: practical, social and emotional perspectives. Seizure. 2014 Nov;23(10):856-63. doi: 10.1016/j.seizure.2014.07.005. Epub 2014 Jul 19. PMID 25086700
Identifiers
NCT: NCT06585618 · IRB-P00047069