A Multicenter Pediatric Deep Brain Stimulation Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Development of a Multi-Center Pediatric DBS Registry

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

Time frame
5 years

Secondary outcomes

1

Data Collection

Secondary objectives will focus on using the data collected to answer important research questions such as : 1. Which patients benefit from DBS? 2. Which clinical variables contribute to the responsiveness or nonresponsivness to DBS? 3. Which implant sites are preferred? 4. What are the long-term effects of DBS in the pediatric population? 5. How does DBS affect quality of life in pediatric patients?

Time frame
5 years

Other outcomes

Sponsors and contacts

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