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NCT Number: NCT06585618

A Multicenter Pediatric Deep Brain Stimulation Registry

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.

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Key information

Conditions

Dystonia Anxiety Disorders Basal Ganglia Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Chorea Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deep Brain Stimulation Dyskinesias Epilepsy Epilepsy in Children Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Movement Disorders in Children Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Neurologic Disorder Neurologic Manifestations Obsessive-Compulsive Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Tic Disorders Tourette Syndrome

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Development of a Multi-Center Pediatric DBS Registry

    Time frame: 5 years

    This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy.

Secondary outcomes

  1. Data Collection

    Time frame: 5 years

    Secondary objectives will focus on using the data collected to answer important research questions such as :

    • Which patients benefit from DBS?
    • Which clinical variables contribute to the responsiveness or nonresponsivness to DBS?
    • Which implant sites are preferred?
    • What are the long-term effects of DBS in the pediatric population?
    • How does DBS affect quality of life in pediatric patients?

Study contacts

Contact information is provided by the study sponsor or research team.

Darius Ebrahimi-Fakhari, MD, PhD

CONTACT

[email protected]

617-355-0097

Kathryn Yang, MBChB, FRCPC

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Multicenter Pediatric Deep Brain Stimulation Registry

Acronym: DBS-R

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 5, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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