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Clinical Trial

The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): a Pivotal, Randomized, Controlled, Double-blinded Multi-site Clinical Trial of Deep Brain Stimulation to Treat Children With Lennox-Gastaut Syndrome

ClinicalTrials.gov4/11/2025ยท04/11/25๐ŸŒ Europe

Summary

The CADET Trial will investigate the effectiveness of deep brain stimulation (DBS) to reduce the frequency of seizures in children with Lennox-Gastaut syndrome (LGS). The CADET Trial will use a non-CE/UKCA marked device - the Picostim DBS system. The SMART-DBS study is a sub-study of the CADET Trial. SMART-DBS will investigate the application of adaptive DBS for the treatment of children with LGS.

Why it matters

This trial represents an important advancement in neurotechnology for treating Lennox Gastaut Syndrome (LGS). If successful, the device-based intervention could provide a new therapeutic option for patients who have not responded adequately to conventional treatments or therapies. The study results may inform future regulatory approval pathways and establish clinical precedent that could benefit broader patient populations with similar conditions.

#Phase 1#Deep Brain Stimulation#Epilepsy#Neurostimulation

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