2022
Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol
Maciel CB, Teixeira FJP, Dickinson KJ, Spana JC, Merck LH, Rabinstein AA, Sergott R, Shan G, Miao G, Peloquin CA, Busl KM, Hirsch LJ. Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol. Neurological Research And Practice 2022, 4: 4. PMID: 35067230, PMCID: PMC8785535, DOI: 10.1186/s42466-022-00168-x.Peer-Reviewed Original ResearchStatus epilepticusClinical trialsVigabatrin levelsClinical trial study protocolPost-cardiac arrest periodRefractory focal-onset seizuresDose-linear pharmacokineticsPrimary feasibility endpointBlinded outcome assessmentEffective adjunctive treatmentSingle loading doseTrial study protocolBrain GABA levelsCardiac arrest survivorsPilot clinical trialLast quantifiable concentrationFocal onset seizuresGABA-ergic pathwaysReports of survivorsConcentration-time curvePrimary pharmacokinetic endpointsFeasibility endpointsAggressive treatmentEligible subjectsNeuronal injury
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