Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial
نویسندگان
چکیده
OBJECTIVE To demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci. METHODS Randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation (RNS System). Subjects with medically intractable partial onset seizures from one or two foci were implanted, and 1 month postimplant were randomized 1:1 to active or sham stimulation. After the fifth postimplant month, all subjects received responsive stimulation in an open label period (OLP) to complete 2 years of postimplant follow-up. RESULTS All 191 subjects were randomized. The percent change in seizures at the end of the blinded period was -37.9% in the active and -17.3% in the sham stimulation group (p = 0.012, Generalized Estimating Equations). The median percent reduction in seizures in the OLP was 44% at 1 year and 53% at 2 years, which represents a progressive and significant improvement with time (p < 0.0001). The serious adverse event rate was not different between subjects receiving active and sham stimulation. Adverse events were consistent with the known risks of an implanted medical device, seizures, and of other epilepsy treatments. There were no adverse effects on neuropsychological function or mood. SIGNIFICANCE Responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe. The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures.
منابع مشابه
Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
OBJECTIVE The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures. METHODS All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS...
متن کاملDifferential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy.
OBJECTIVE Responsive neurostimulation decreases the frequency of disabling seizures when used as an adjunctive therapy in patients with medically refractory partial-onset seizures. The effect of long-term responsive neurostimulation on neuropsychological performance has not yet been established. METHODS Neuropsychological data were collected from subjects participating in the open-label arm o...
متن کامل7.01.143 Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy
[TOP] Responsive neurostimulation (RNS) may be considered medically necessary for patients with partial epilepsy who meet ALL of the following criteria: Are 18 years or older. Have a diagnosis of partial-onset seizures with 1 or 2 well-localized seizure foci identified. Have an average of 3 or more disabling seizures (e.g., motor partial seizures, complex partial seizures, or secondary ge...
متن کاملBrain-responsive neurostimulation in patients with medically intractable seizures arising from eloquent and other neocortical areas.
OBJECTIVE Evaluate the seizure-reduction response and safety of brain-responsive stimulation in adults with medically intractable partial-onset seizures of neocortical origin. METHODS Patients with partial seizures of neocortical origin were identified from prospective clinical trials of a brain-responsive neurostimulator (RNS System, NeuroPace). The seizure reduction over years 2-6 postimpla...
متن کاملQuality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation
PURPOSE The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. METHODS The study was a multicenter randomized controlled double-blinded t...
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عنوان ژورنال:
دوره 55 شماره
صفحات -
تاریخ انتشار 2014