title: Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy.
abstract: Evaluate the seizure-reduction response and safety of mesial temporal lobe (MTL) brain-responsive stimulation in adults with medically intractable partial-onset seizures of mesial temporal lobe origin.
  
  
  
  Subjects with mesial temporal lobe epilepsy (MTLE) were identified from prospective clinical trials of a brain-responsive neurostimulator (RNS System, NeuroPace). The seizure reduction over years 2-6 postimplantation was calculated by assessing the seizure frequency compared to a preimplantation baseline. Safety was assessed based on reported adverse events.
  
  
  
  There were 111 subjects with MTLE; 72% of subjects had bilateral MTL onsets and 28% had unilateral onsets. Subjects had one to four leads placed; only two leads could be connected to the device. Seventy-six subjects had depth leads only, 29 had both depth and strip leads, and 6 had only strip leads. The mean follow-up was 6.1 ± (standard deviation) 2.2 years. The median percent seizure reduction was 70% (last observation carried forward). Twenty-nine percent of subjects experienced at least one seizure-free period of 6 months or longer, and 15% experienced at least one seizure-free period of 1 year or longer. There was no difference in seizure reduction in subjects with and without mesial temporal sclerosis (MTS), bilateral MTL onsets, prior resection, prior intracranial monitoring, and prior vagus nerve stimulation. In addition, seizure reduction was not dependent on the location of depth leads relative to the hippocampus. The most frequent serious device-related adverse event was soft tissue implant-site infection (overall rate, including events categorized as device-related, uncertain, or not device-related: 0.03 per implant year, which is not greater than with other neurostimulation devices).
  
  
  
  Brain-responsive stimulation represents a safe and effective treatment option for patients with medically intractable epilepsy, including patients with unilateral or bilateral MTLE who are not candidates for temporal lobectomy or who have failed a prior MTL resection.
authors.affiliation: Saint Barnabas Health, Livingston, New Jersey, U.S.A.
authors.forename: Eric B
authors.initials: EB
authors.lastname: Geller
authors.affiliation: NeuroPace, Inc., Mountain View, California, U.S.A.
authors.forename: Tara L
authors.initials: TL
authors.lastname: Skarpaas
authors.affiliation: Emory University, Atlanta, Georgia, U.S.A.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Gross
authors.affiliation: Saint Luke's Hospital, New York City, New York, U.S.A.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Goodman
authors.affiliation: Henry Ford Hospital, Detroit, Michigan, U.S.A.
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Barkley
authors.affiliation: Columbia University Medical Center, New York City, New York, U.S.A.
authors.forename: Carl W
authors.initials: CW
authors.lastname: Bazil
authors.affiliation: University of Rochester Medical Center, Rochester, New York, U.S.A.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Berg
authors.affiliation: Johns Hopkins University, Baltimore, Maryland, U.S.A.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Bergey
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts, U.S.A.
authors.forename: Sydney S
authors.initials: SS
authors.lastname: Cash
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts, U.S.A.
authors.forename: Andrew J
authors.identifier: 0000-0002-0828-826X
authors.initials: AJ
authors.lastname: Cole
authors.affiliation: Yale School of Medicine, New Haven, Connecticut, U.S.A.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Duckrow
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina, U.S.A.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Edwards
authors.affiliation: University of Florida College of Medicine, Gainesville, Florida, U.S.A.
authors.forename: Stephan
authors.initials: S
authors.lastname: Eisenschenk
authors.affiliation: University of Rochester Medical Center, Rochester, New York, U.S.A.
authors.forename: James
authors.initials: J
authors.lastname: Fessler
authors.affiliation: University of Virginia, Charlottesville, Virginia, U.S.A.
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Fountain
authors.affiliation: Baylor College of Medicine, Houston, Texas, U.S.A.
authors.forename: Alicia M
authors.initials: AM
authors.lastname: Goldman
authors.affiliation: Swedish Medical Center, Seattle, Washington, U.S.A.
authors.forename: Ryder P
authors.initials: RP
authors.lastname: Gwinn
authors.affiliation: University of Southern California, Los Angeles, California, U.S.A.
authors.forename: Christianne
authors.initials: C
authors.lastname: Heck
authors.affiliation: Via Christi Clinic, Wichita, Kansas, U.S.A.
authors.forename: Aamar
authors.initials: A
authors.lastname: Herekar
authors.affiliation: Yale School of Medicine, New Haven, Connecticut, U.S.A.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Hirsch
authors.affiliation: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, U.S.A.
authors.forename: Barbara C
authors.initials: BC
authors.lastname: Jobst
authors.affiliation: California Pacific Medical Center, San Francisco, California, U.S.A.
authors.forename: David
authors.initials: D
authors.lastname: King-Stephens
authors.affiliation: Weill Cornell Medicine, New York City, New York, U.S.A.
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Labar
authors.affiliation: Inova Medical Group, Fairfax, Virginia, U.S.A.
authors.forename: James W
authors.initials: JW
authors.lastname: Leiphart
authors.affiliation: Mayo Clinic College of Medicine, Rochester, Minnesota, U.S.A.
authors.forename: W Richard
authors.initials: WR
authors.lastname: Marsh
authors.affiliation: Stanford University School of Medicine, Stanford, California, U.S.A.
authors.forename: Kimford J
authors.initials: KJ
authors.lastname: Meador
authors.affiliation: Baylor College of Medicine, Houston, Texas, U.S.A.
authors.forename: Eli M
authors.initials: EM
authors.lastname: Mizrahi
authors.affiliation: Augusta University, Augusta, Georgia, U.S.A.
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Murro
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, U.S.A.
authors.forename: Dileep R
authors.initials: DR
authors.lastname: Nair
authors.affiliation: Mayo Clinic College of Medicine, Scottsdale, Arizona, U.S.A.
authors.forename: Katherine H
authors.initials: KH
authors.lastname: Noe
authors.affiliation: Augusta University, Augusta, Georgia, U.S.A.
authors.forename: Yong D
authors.initials: YD
authors.lastname: Park
authors.affiliation: University of Wisconsin, Madison, Wisconsin, U.S.A.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Rutecki
authors.affiliation: Indiana University, Indianapolis, Indiana, U.S.A.
authors.forename: Vicenta
authors.initials: V
authors.lastname: Salanova
authors.affiliation: Nemours Foundation, Jacksonville, Florida, U.S.A.
authors.forename: Raj D
authors.initials: RD
authors.lastname: Sheth
authors.affiliation: George Washington University School of Medicine & Health Sciences, Washington, Washington DC, U.S.A.
authors.forename: Donald C
authors.initials: DC
authors.lastname: Shields
authors.affiliation: Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.
authors.forename: Christopher
authors.initials: C
authors.lastname: Skidmore
authors.affiliation: Rush University Medical Center, Chicago, Illinois, U.S.A.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Smith
authors.affiliation: Oregon Health & Science University, Portland, Oregon, U.S.A.
authors.forename: David C
authors.initials: DC
authors.lastname: Spencer
authors.affiliation: Columbia University Medical Center, New York City, New York, U.S.A.
authors.forename: Shraddha
authors.initials: S
authors.lastname: Srinivasan
authors.affiliation: Mayo Clinic College of Medicine, Jacksonville, Florida, U.S.A.
authors.forename: William
authors.initials: W
authors.lastname: Tatum
authors.affiliation: Baylor College of Medicine, Houston, Texas, U.S.A.
authors.forename: Paul C
authors.initials: PC
authors.lastname: Van Ness
authors.affiliation: Valley Medical Center, Renton, Washington, U.S.A.
authors.forename: David G
authors.initials: DG
authors.lastname: Vossler
authors.affiliation: Mayo Clinic College of Medicine, Jacksonville, Florida, U.S.A.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Wharen
authors.affiliation: Mayo Clinic College of Medicine, Rochester, Minnesota, U.S.A.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Worrell
authors.affiliation: Baylor College of Medicine, Houston, Texas, U.S.A.
authors.forename: Daniel
authors.initials: D
authors.lastname: Yoshor
authors.affiliation: Mayo Clinic College of Medicine, Scottsdale, Arizona, U.S.A.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Zimmerman
authors.affiliation: NeuroPace, Inc., Mountain View, California, U.S.A.
authors.forename: Kathy
authors.initials: K
authors.lastname: Cicora
authors.affiliation: NeuroPace, Inc., Mountain View, California, U.S.A.
authors.forename: Felice T
authors.initials: FT
authors.lastname: Sun
authors.affiliation: NeuroPace, Inc., Mountain View, California, U.S.A.|Stanford University School of Medicine, Stanford, California, U.S.A.
authors.forename: Martha J
authors.initials: MJ
authors.lastname: Morrell
mesh_terms: D000293:Adolescent; D000328:Adult; D001921:Brain / Q000503:physiopathology*; D046690:Deep Brain Stimulation / Q000379:methods*; D004292:Dominance, Cerebral / Q000502:physiology; D000069279:Drug Resistant Epilepsy / Q000503:physiopathology* / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D004569:Electroencephalography; D004828:Epilepsies, Partial / Q000503:physiopathology* / Q000628:therapy*; D004833:Epilepsy, Temporal Lobe / Q000503:physiopathology* / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D055815:Young Adult
keywords: Closed-loop; Focal stimulation; Hippocampus; Neuromodulation; Partial seizures