Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy

Eric B. Geller, Tara L. Skarpaas, Robert E. Gross, Robert R. Goodman, Gregory L. Barkley, Carl W. Bazil, Michael J. Berg, Gregory K. Bergey, Sydney S. Cash, Andrew J. Cole, Robert B. Duckrow, Jonathan C. Edwards, Stephan Eisenschenk, James Fessler, Nathan B. Fountain, Alicia M. Goldman, Ryder P. Gwinn, Christianne Heck, Aamar Herekar, Lawrence J. HirschBarbara C. Jobst, David King-Stephens, Douglas R. Labar, James W. Leiphart, W. Richard Marsh, Kimford J. Meador, Eli M. Mizrahi, Anthony M. Murro, Dileep R. Nair, Katherine H. Noe, Yong D. Park, Paul A. Rutecki, Vicenta Salanova, Raj D. Sheth, Donald C. Shields, Christopher Skidmore, Michael C. Smith, David C. Spencer, Shraddha Srinivasan, William Tatum, Paul C. Van Ness, David G. Vossler, Robert E. Wharen, Gregory A. Worrell, Daniel Yoshor, Richard S. Zimmerman, Kathy Cicora, Felice T. Sun, Martha J. Morrell

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Objective: 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. Methods: 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. Results: 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). Significance: 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.

Original languageEnglish (US)
Pages (from-to)994-1004
Number of pages11
JournalEpilepsia
Volume58
Issue number6
DOIs
StatePublished - Jun 1 2017

Fingerprint

Temporal Lobe Epilepsy
Seizures
Temporal Lobe
Brain
Equipment and Supplies
Vagus Nerve Stimulation
Safety
Sclerosis
Hippocampus
Observation
Clinical Trials

Keywords

  • Closed-loop
  • Focal stimulation
  • Hippocampus
  • Neuromodulation
  • Partial seizures

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Geller, E. B., Skarpaas, T. L., Gross, R. E., Goodman, R. R., Barkley, G. L., Bazil, C. W., ... Morrell, M. J. (2017). Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy. Epilepsia, 58(6), 994-1004. https://doi.org/10.1111/epi.13740

Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy. / Geller, Eric B.; Skarpaas, Tara L.; Gross, Robert E.; Goodman, Robert R.; Barkley, Gregory L.; Bazil, Carl W.; Berg, Michael J.; Bergey, Gregory K.; Cash, Sydney S.; Cole, Andrew J.; Duckrow, Robert B.; Edwards, Jonathan C.; Eisenschenk, Stephan; Fessler, James; Fountain, Nathan B.; Goldman, Alicia M.; Gwinn, Ryder P.; Heck, Christianne; Herekar, Aamar; Hirsch, Lawrence J.; Jobst, Barbara C.; King-Stephens, David; Labar, Douglas R.; Leiphart, James W.; Marsh, W. Richard; Meador, Kimford J.; Mizrahi, Eli M.; Murro, Anthony M.; Nair, Dileep R.; Noe, Katherine H.; Park, Yong D.; Rutecki, Paul A.; Salanova, Vicenta; Sheth, Raj D.; Shields, Donald C.; Skidmore, Christopher; Smith, Michael C.; Spencer, David C.; Srinivasan, Shraddha; Tatum, William; Van Ness, Paul C.; Vossler, David G.; Wharen, Robert E.; Worrell, Gregory A.; Yoshor, Daniel; Zimmerman, Richard S.; Cicora, Kathy; Sun, Felice T.; Morrell, Martha J.

In: Epilepsia, Vol. 58, No. 6, 01.06.2017, p. 994-1004.

Research output: Contribution to journalArticle

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 2017, 'Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy', Epilepsia, vol. 58, no. 6, pp. 994-1004. https://doi.org/10.1111/epi.13740
Geller EB, Skarpaas TL, Gross RE, Goodman RR, Barkley GL, Bazil CW et al. Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy. Epilepsia. 2017 Jun 1;58(6):994-1004. https://doi.org/10.1111/epi.13740
Geller, Eric B. ; Skarpaas, Tara L. ; Gross, Robert E. ; Goodman, Robert R. ; Barkley, Gregory L. ; Bazil, Carl W. ; Berg, Michael J. ; Bergey, Gregory K. ; Cash, Sydney S. ; Cole, Andrew J. ; Duckrow, Robert B. ; Edwards, Jonathan C. ; Eisenschenk, Stephan ; Fessler, James ; Fountain, Nathan B. ; Goldman, Alicia M. ; Gwinn, Ryder P. ; Heck, Christianne ; Herekar, Aamar ; Hirsch, Lawrence J. ; Jobst, Barbara C. ; King-Stephens, David ; Labar, Douglas R. ; Leiphart, James W. ; Marsh, W. Richard ; Meador, Kimford J. ; Mizrahi, Eli M. ; Murro, Anthony M. ; Nair, Dileep R. ; Noe, Katherine H. ; Park, Yong D. ; Rutecki, Paul A. ; Salanova, Vicenta ; Sheth, Raj D. ; Shields, Donald C. ; Skidmore, Christopher ; Smith, Michael C. ; Spencer, David C. ; Srinivasan, Shraddha ; Tatum, William ; Van Ness, Paul C. ; Vossler, David G. ; Wharen, Robert E. ; Worrell, Gregory A. ; Yoshor, Daniel ; Zimmerman, Richard S. ; Cicora, Kathy ; Sun, Felice T. ; Morrell, Martha J. / Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy. In: Epilepsia. 2017 ; Vol. 58, No. 6. pp. 994-1004.
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abstract = "Objective: 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. Methods: 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. Results: 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). Significance: 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.",
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TY - JOUR

T1 - Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy

AU - Geller, Eric B.

AU - Skarpaas, Tara L.

AU - Gross, Robert E.

AU - Goodman, Robert R.

AU - Barkley, Gregory L.

AU - Bazil, Carl W.

AU - Berg, Michael J.

AU - Bergey, Gregory K.

AU - Cash, Sydney S.

AU - Cole, Andrew J.

AU - Duckrow, Robert B.

AU - Edwards, Jonathan C.

AU - Eisenschenk, Stephan

AU - Fessler, James

AU - Fountain, Nathan B.

AU - Goldman, Alicia M.

AU - Gwinn, Ryder P.

AU - Heck, Christianne

AU - Herekar, Aamar

AU - Hirsch, Lawrence J.

AU - Jobst, Barbara C.

AU - King-Stephens, David

AU - Labar, Douglas R.

AU - Leiphart, James W.

AU - Marsh, W. Richard

AU - Meador, Kimford J.

AU - Mizrahi, Eli M.

AU - Murro, Anthony M.

AU - Nair, Dileep R.

AU - Noe, Katherine H.

AU - Park, Yong D.

AU - Rutecki, Paul A.

AU - Salanova, Vicenta

AU - Sheth, Raj D.

AU - Shields, Donald C.

AU - Skidmore, Christopher

AU - Smith, Michael C.

AU - Spencer, David C.

AU - Srinivasan, Shraddha

AU - Tatum, William

AU - Van Ness, Paul C.

AU - Vossler, David G.

AU - Wharen, Robert E.

AU - Worrell, Gregory A.

AU - Yoshor, Daniel

AU - Zimmerman, Richard S.

AU - Cicora, Kathy

AU - Sun, Felice T.

AU - Morrell, Martha J.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Objective: 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. Methods: 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. Results: 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). Significance: 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.

AB - Objective: 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. Methods: 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. Results: 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). Significance: 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.

KW - Closed-loop

KW - Focal stimulation

KW - Hippocampus

KW - Neuromodulation

KW - Partial seizures

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