RECRUITING

A Multicenter Pediatric Deep Brain Stimulation Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multicenter Pediatric Deep Brain Stimulation Registry

Quick Facts

Study Start:2024-07-30
Study Completion:2029-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female or male patients between ages of 0-18 years.
  2. * Having received or scheduled to receive DBS for any neurological movement disorder.
  3. * Parents or legal guardians are able to provide written consent for prospective enrollment.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Darius Ebrahimi-Fakhari, MD, PhD
CONTACT
617-355-0097
movementdisorders@children.harvard.edu
Kathryn Yang, MBChB, FRCPC
CONTACT
movementdisorders@children.harvard.edu

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30
Study Completion Date2029-07-30

Study Record Updates

Study Start Date2024-07-30
Study Completion Date2029-07-30

Terms related to this study

Keywords Provided by Researchers

  • Deep Brain Stimulation
  • DBS
  • movement disorder
  • movement disorders in children
  • dystonia
  • chorea
  • dyskinesia
  • epilepsy

Additional Relevant MeSH Terms

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