Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy
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This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years and provides significant and sustained reductions in the frequency of FOS with improved QOL.Abstract:
OBJECTIVE To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. METHODS Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory. RESULTS Of 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a ≥90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed χ2). CONCLUSIONS Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low. CLINICALTRIALSGOV IDENTIFIER NCT00572195. CLASSIFICATION OF EVIDENCE This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.read more
Citations
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Forecasting seizure risk in adults with focal epilepsy: a development and validation study.
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TL;DR: In this paper, the authors analyzed data from continuous intracranial electroencephalography (cEEG) and seizure diaries collected between January 19, 2004, and May 18, 2018, with durations up to 10 years.
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TL;DR: In this article, the most relevant clinical and pathogenetic issues related to drug-resistant epilepsy were analyzed and the current evidence about the use of available antiseizure medications and the alternative non-pharmacological approaches.
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Neuromodulation in epilepsy: state-of-the-art approved therapies.
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Long-term brain network reorganization predicts responsive neurostimulation outcomes for focal epilepsy.
TL;DR: This paper found that patients with the greatest therapeutic benefit undergo progressive, frequency-dependent reorganization of interictal functional connectivity, and the extent of this reorganization scales directly with seizure reduction and emerges within the first year of RNS treatment.
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Responsive cortical stimulation for the treatment of medically intractable partial epilepsy
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