2020
Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy
Nair DR, Laxer KD, Weber PB, Murro AM, Park YD, Barkley GL, Smith BJ, Gwinn RP, Doherty MJ, Noe KH, Zimmerman RS, Bergey GK, Anderson WS, Heck C, Liu CY, Lee RW, Sadler T, Duckrow RB, Hirsch LJ, Wharen RE, Tatum W, Srinivasan S, McKhann GM, Agostini MA, Alexopoulos AV, Jobst BC, Roberts DW, Salanova V, Witt TC, Cash SS, Cole AJ, Worrell GA, Lundstrom BN, Edwards JC, Halford JJ, Spencer DC, Ernst L, Skidmore CT, Sperling MR, Miller I, Geller EB, Berg MJ, Fessler AJ, Rutecki P, Goldman AM, Mizrahi EM, Gross RE, Shields DC, Schwartz TH, Labar DR, Fountain NB, Elias WJ, Olejniczak PW, Villemarette-Pittman NR, Eisenschenk S, Roper SN, Boggs JG, Courtney TA, Sun FT, Seale CG, Miller KL, Skarpaas TL, Morrell MJ. Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy. Neurology 2020, 95: 10.1212/wnl.0000000000010154. PMID: 32690786, PMCID: PMC7538230, DOI: 10.1212/wnl.0000000000010154.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedDepressive DisorderDrug Resistant EpilepsyElectric Stimulation TherapyEpilepsies, PartialFemaleFollow-Up StudiesHumansImplantable NeurostimulatorsIntracranial HemorrhagesMaleMemory DisordersMiddle AgedProspective StudiesProsthesis-Related InfectionsQuality of LifeRandomized Controlled Trials as TopicStatus EpilepticusSudden Unexpected Death in EpilepsySuicideTreatment OutcomeYoung AdultConceptsBrain-responsive neurostimulationQuality of lifeFocal onset seizuresAdverse eventsSeizure frequencyIntractable focal onset seizuresProspective open-label trialOverall QOLOpen-label trialSerious adverse eventsClass IV evidenceMedian percent reductionSudden unexplained deathMedian percent changeSeizure-free periodQOLIE-89SUDEP ratesLabel trialSeizure freedomEpilepsy ratesFocal seizuresOnset seizuresEpilepsy InventoryAcceptable safetyFocal epilepsy
2018
Sudden unexpected death in epilepsy in patients treated with brain‐responsive neurostimulation
Devinsky O, Friedman D, Duckrow RB, Fountain NB, Gwinn RP, Leiphart JW, Murro AM, Van Ness PC. Sudden unexpected death in epilepsy in patients treated with brain‐responsive neurostimulation. Epilepsia 2018, 59: 555-561. PMID: 29336029, DOI: 10.1111/epi.13998.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedBrainDeath, SuddenElectric Stimulation TherapyElectrocorticographyEpilepsyFemaleHumansImplantable NeurostimulatorsMaleMiddle AgedYoung AdultConceptsSudden unexpected deathDefinite SUDEPEpileptiform activityUnexpected deathBrain-responsive neurostimulationFrequent epileptiform activityDrug Administration approvalRNS SystemTime of deathSUDEP ratesWitnessed seizurePlacebo armResective surgerySUDEP riskClinical featuresImplant yearAdministration approvalClinical trialsEpilepsy patientsSUDEPPatientsSeizuresDrug studiesU.S. FoodDeath
2014
Two‐year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial
Heck CN, King‐Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two‐year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial. Epilepsia 2014, 55: 432-441. PMID: 24621228, PMCID: PMC4233950, DOI: 10.1111/epi.12534.Peer-Reviewed Original ResearchConceptsIntractable partial-onset seizuresPartial-onset seizuresOpen-label periodResponsive stimulationSeizure focusSeizure reductionOnset seizuresSham stimulationIntractable partial onset epilepsySerious adverse event ratesFocal cortical stimulationPartial-onset epilepsyAdverse event ratesFrequency of seizuresMedian percent reductionAdditional treatment optionsSham stimulation groupBlinded periodMonth postimplantAdjunctive therapyAdverse eventsOnset epilepsyPivotal trialsCortical stimulationTreatment options