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 epilepsyMesial temporal resection following long‐term ambulatory intracranial EEG monitoring with a direct brain‐responsive neurostimulation system
Hirsch LJ, Mirro EA, Salanova V, Witt TC, Drees CN, Brown M, Lee RW, Sadler TL, Felton EA, Rutecki P, Shin HW, Hadar E, Hegde M, Rao VR, Mnatsakanyan L, Madhavan DS, Zakaria TJ, Liu AA, Heck CN, Greenwood JE, Bigelow JK, Nair DR, Alexopoulos AV, Mackow M, Edwards JC, Sotudeh N, Kuzniecky RI, Gwinn RP, Doherty MJ, Geller EB, Morrell MJ. Mesial temporal resection following long‐term ambulatory intracranial EEG monitoring with a direct brain‐responsive neurostimulation system. Epilepsia 2020, 61: 408-420. PMID: 32072621, PMCID: PMC7154711, DOI: 10.1111/epi.16442.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnterior Temporal LobectomyDrug Resistant EpilepsyElectric Stimulation TherapyElectrocorticographyEpilepsy, Temporal LobeFemaleHumansImplantable NeurostimulatorsMaleMiddle AgedMonitoring, AmbulatoryNeurosurgical ProceduresRetrospective StudiesTemporal LobeTreatment OutcomeYoung AdultConceptsMTL resectionElectrographic seizuresTemporal lobe seizure onsetClinical seizure reductionMesial temporal resectionIntracranial EEG monitoringRNS SystemBitemporal epilepsySeizure reductionSeizure outcomeTemporal resectionPrimary outcomeRefractory epilepsyAdditional patientsEpilepsy centersUnilateral onsetBilateral onsetIcEEG recordingsSeizure onsetMTL epilepsyMedian reductionResectionPatientsEEG monitoringIcEEG data
2019
Early detection rate changes from a brain‐responsive neurostimulation system predict efficacy of newly added antiseizure drugs
Quraishi IH, Mercier MR, Skarpaas TL, Hirsch LJ. Early detection rate changes from a brain‐responsive neurostimulation system predict efficacy of newly added antiseizure drugs. Epilepsia 2019, 61: 138-148. PMID: 31849045, PMCID: PMC7003822, DOI: 10.1111/epi.16412.Peer-Reviewed Original ResearchMeSH KeywordsAnticonvulsantsClinical Trials as TopicDrug Resistant EpilepsyElectric Stimulation TherapyElectrocorticographyHumansRetrospective StudiesTreatment OutcomeConceptsPositive predictive valueEpisode startsLonger episodesSystem patientsPredictive valueFirst weekLong-term treatment trialsBrain-responsive neurostimulationSingle epilepsy centerSingle-center cohortRefractory focal epilepsyGreater reductionMedication adjustmentsClinical improvementClinical responseSeizure frequencyAntiseizure drugsCenter cohortMulticenter cohortEpilepsy centersMedication trialsEffective medicationsEfficacy measuresTreatment trialsFocal epilepsy
2017
Brain‐responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy
Geller EB, Skarpaas TL, Gross RE, Goodman RR, Barkley GL, Bazil CW, Berg MJ, Bergey GK, Cash SS, Cole AJ, Duckrow RB, Edwards JC, Eisenschenk S, Fessler J, Fountain NB, Goldman AM, Gwinn RP, Heck C, Herekar A, Hirsch LJ, Jobst BC, King‐Stephens D, Labar DR, Leiphart JW, Marsh WR, Meador KJ, Mizrahi EM, Murro AM, Nair DR, Noe KH, Park YD, Rutecki PA, Salanova V, Sheth RD, Shields DC, Skidmore C, Smith MC, Spencer DC, Srinivasan S, Tatum W, Van Ness PC, Vossler DG, Wharen RE, Worrell GA, Yoshor D, Zimmerman RS, Cicora K, Sun FT, Morrell MJ. Brain‐responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy. Epilepsia 2017, 58: 994-1004. PMID: 28398014, DOI: 10.1111/epi.13740.Peer-Reviewed Original ResearchConceptsMesial temporal lobe epilepsyMesial temporal sclerosisSeizure-free periodTemporal lobe epilepsySeizure reductionAdverse eventsLobe epilepsyIntractable mesial temporal lobe epilepsySerious device-related adverse eventsIntractable partial-onset seizuresMedian percent seizure reductionMesial temporal lobe originBilateral mesial temporal lobe epilepsyDevice-related adverse eventsBrain-responsive neurostimulationImplant site infectionPercent seizure reductionPartial-onset seizuresProspective clinical trialsTemporal lobe originVagus nerve stimulationEffective treatment optionPercent of subjectsPreimplantation baselineTemporal sclerosisBrain‐responsive neurostimulation in patients with medically intractable seizures arising from eloquent and other neocortical areas
Jobst BC, Kapur R, Barkley GL, Bazil CW, Berg MJ, Bergey GK, Boggs JG, Cash SS, Cole AJ, Duchowny MS, Duckrow RB, Edwards JC, Eisenschenk S, Fessler AJ, Fountain NB, Geller EB, Goldman AM, Goodman RR, Gross RE, Gwinn RP, Heck C, Herekar AA, Hirsch LJ, King‐Stephens D, Labar DR, Marsh WR, Meador KJ, Miller I, Mizrahi EM, Murro AM, Nair DR, Noe KH, Olejniczak PW, Park YD, Rutecki P, Salanova V, Sheth RD, Skidmore C, Smith MC, Spencer DC, Srinivasan S, Tatum W, Van Ness P, Vossler DG, Wharen RE, Worrell GA, Yoshor D, Zimmerman RS, Skarpaas TL, Morrell MJ. Brain‐responsive neurostimulation in patients with medically intractable seizures arising from eloquent and other neocortical areas. Epilepsia 2017, 58: 1005-1014. PMID: 28387951, DOI: 10.1111/epi.13739.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultBrain MappingCerebral CortexDeep Brain StimulationDrug Resistant EpilepsyElectric Stimulation TherapyElectrodes, ImplantedElectroencephalographyEpilepsies, PartialEpilepsy, Complex PartialEpilepsy, Partial, MotorEpilepsy, Tonic-ClonicFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedNeocortexYoung AdultConceptsSeizure-free periodSeizure reductionNeocortical onsetSeizure onsetNeocortical originIntractable partial-onset seizuresMedian percent seizure reductionBrain-responsive neurostimulationChronic neurologic deficitsPercent seizure reductionPrior epilepsy surgeryPartial-onset seizuresPercent of patientsProspective clinical trialsNormal MRI findingsVagus nerve stimulationEffective treatment optionEloquent cortical areasRate of infectionMagnetic resonance imagingPreimplantation baselineMRI lesionsAdverse eventsNeurologic deficitsPerioperative hemorrhage
2014
Skepticism should not result in ignoring a treatment option
Benbadis S, Helmers S, Hirsch L, Sirven J, Vale FL, Wheless J. Skepticism should not result in ignoring a treatment option. Neurology 2014, 83: 849-850. PMID: 25156351, DOI: 10.1212/wnl.0000000000000743.Peer-Reviewed Original ResearchYes, neurostimulation has a role in the management of epilepsy
Benbadis S, Helmers S, Hirsch L, Sirven J, Vale FL, Wheless J. Yes, neurostimulation has a role in the management of epilepsy. Neurology 2014, 83: 845-847. PMID: 25156348, DOI: 10.1212/wnl.0000000000000739.Peer-Reviewed Original ResearchTwo‐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