A Multicenter Pediatric Deep Brain Stimulation Registry

NCT ID: NCT06585618

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2029-07-30

Brief Summary

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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

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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.

Conditions

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Dystonia Epilepsy in Children Cerebral Palsy Tourette Syndrome Obsessive-Compulsive Disorder Neurologic Disorder Movement Disorders in Children Movement Disorders Deep Brain Stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Darius Ebrahimi-Fakhari

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Darius Ebrahimi-Fakhari, MD, PhD

Role: CONTACT

617-355-0097

Kathryn Yang, MBChB, FRCPC

Role: CONTACT

Facility Contacts

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Darius Ebrahimi-Fakhari, MD, PhD.

Role: primary

617-355-0097

Kathryn Yang, MD

Role: backup

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-P00047069

Identifier Type: -

Identifier Source: org_study_id

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