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The Responsive Direct Cortical Stimulation (RNS) system is FDA approved for adjunctive therapy in adults with medically intractable partial-onset seizures localized to no more than two epileptogenic foci. A multicenter, double-blinded, randomized, sham-stimulation, controlled trial had provided class I evidence for its efficacy in seizure reduction. Now, researchers report results of the manufacturer-funded long-term treatment (LTT) study, evaluating long-term efficacy and safety outcomes in the same patient group.
Of 256 participants implanted with the RNS system, 230 were enrolled in the LTT study, and 191 remained to the date of analysis (mean follow-up, 5.4 patient implant years). Reduction in seizure frequency increased progressively fo…