Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.
PMID: 42566800 ·
Suna Jung, Samuel Molot-Toker, Thiemo F Dinger, Arjun Balachandar, Birra Taha, Karim Mithani, Sara Breitbart, MyLoi Huynh, Fay Kisteroff, Seetha Sriharan, Lindsey M Vogt, Andrea LeBlanc-Millar, Darius Ebrahimi-Fakhari, Kathryn Yang, Marcella Ruppert-Gomez, Scellig S Stone, Weston T Northam, Nisha Gadgil, Jeffrey S Raskin, Alexander G Weil, Aristides Hadjinicolaou, Inge A Meijer, Alfonso Fasano, Carolina Gorodetsky, George M Ibrahim
Abstract
In the US, deep brain stimulation (DBS) is accessible to pediatric patients with dystonia who are 7 years of age and older through an FDA Humanitarian Device Exemption (HDE). The aim of this study was to assess the safety, feasibility, and outcomes of DBS for dystonia in children younger than 7 years of age who are excluded from the FDA HDE. Data were collected (February 2015-December 2025) through The Child & Youth Comprehensive Longitudinal Database for DBS, which is a prospective registry of
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