RNS System Feasibility Study of Thalamocortical Brain-Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome
Brief description of study
The purpose of the RNS System LGS Feasibility Study is to show that the NeuroPace
RNS® System medical device is safe well and effective (works well) as an additional
treatment in reducing the frequency of generalized seizures in individuals with LGS,
Lennox-Gastaut Syndrome, who are 12 years of age or older. Specifically, people
participating have LGS, seizures not controlled by antiseizure medications, and
frequent and disabling drop seizures (atonic, tonic, tonic-clonic, and/or myoclonic
seizures).
The federal Food and Drug Administration (FDA) has approved the RNS System for
use in patients 18 years and older with hard-to-treat focal onset seizures. The RNS
System is being used in this research and is considered investigational.
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