Eric B Geller1, Tara L Skarpaas2, Robert E Gross3, Robert R Goodman4, Gregory L Barkley5, Carl W Bazil6, Michael J Berg7, Gregory K Bergey8, Sydney S Cash9, Andrew J Cole9, Robert B Duckrow10, Jonathan C Edwards11, Stephan Eisenschenk12, James Fessler7, Nathan B Fountain13, Alicia M Goldman14, Ryder P Gwinn15, Christianne Heck16, Aamar Herekar17, Lawrence J Hirsch10, Barbara C Jobst18, David King-Stephens19, Douglas R Labar20, James W Leiphart21, W Richard Marsh22, Kimford J Meador23, Eli M Mizrahi14, Anthony M Murro24, Dileep R Nair25, Katherine H Noe26, Yong D Park24, Paul A Rutecki27, Vicenta Salanova28, Raj D Sheth29, Donald C Shields30, Christopher Skidmore31, Michael C Smith32, David C Spencer33, Shraddha Srinivasan6, William Tatum34, Paul C Van Ness14, David G Vossler35, Robert E Wharen34, Gregory A Worrell22, Daniel Yoshor14, Richard S Zimmerman26, Kathy Cicora2, Felice T Sun2, Martha J Morrell2,23. 1. Saint Barnabas Health, Livingston, New Jersey, U.S.A. 2. NeuroPace, Inc., Mountain View, California, U.S.A. 3. Emory University, Atlanta, Georgia, U.S.A. 4. Saint Luke's Hospital, New York City, New York, U.S.A. 5. Henry Ford Hospital, Detroit, Michigan, U.S.A. 6. Columbia University Medical Center, New York City, New York, U.S.A. 7. University of Rochester Medical Center, Rochester, New York, U.S.A. 8. Johns Hopkins University, Baltimore, Maryland, U.S.A. 9. Massachusetts General Hospital, Boston, Massachusetts, U.S.A. 10. Yale School of Medicine, New Haven, Connecticut, U.S.A. 11. Medical University of South Carolina, Charleston, South Carolina, U.S.A. 12. University of Florida College of Medicine, Gainesville, Florida, U.S.A. 13. University of Virginia, Charlottesville, Virginia, U.S.A. 14. Baylor College of Medicine, Houston, Texas, U.S.A. 15. Swedish Medical Center, Seattle, Washington, U.S.A. 16. University of Southern California, Los Angeles, California, U.S.A. 17. Via Christi Clinic, Wichita, Kansas, U.S.A. 18. Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, U.S.A. 19. California Pacific Medical Center, San Francisco, California, U.S.A. 20. Weill Cornell Medicine, New York City, New York, U.S.A. 21. Inova Medical Group, Fairfax, Virginia, U.S.A. 22. Mayo Clinic College of Medicine, Rochester, Minnesota, U.S.A. 23. Stanford University School of Medicine, Stanford, California, U.S.A. 24. Augusta University, Augusta, Georgia, U.S.A. 25. Cleveland Clinic, Cleveland, Ohio, U.S.A. 26. Mayo Clinic College of Medicine, Scottsdale, Arizona, U.S.A. 27. University of Wisconsin, Madison, Wisconsin, U.S.A. 28. Indiana University, Indianapolis, Indiana, U.S.A. 29. Nemours Foundation, Jacksonville, Florida, U.S.A. 30. George Washington University School of Medicine & Health Sciences, Washington, Washington DC, U.S.A. 31. Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A. 32. Rush University Medical Center, Chicago, Illinois, U.S.A. 33. Oregon Health & Science University, Portland, Oregon, U.S.A. 34. Mayo Clinic College of Medicine, Jacksonville, Florida, U.S.A. 35. Valley Medical Center, Renton, Washington, U.S.A.
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.
RCT Entities:
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.
Authors: Evon S Ereifej; Courtney E Shell; Jonathon S Schofield; Hamid Charkhkar; Ivana Cuberovic; Alan D Dorval; Emily L Graczyk; Takashi D Y Kozai; Kevin J Otto; Dustin J Tyler; Cristin G Welle; Alik S Widge; José Zariffa; Chet T Moritz; Dennis J Bourbeau; Paul D Marasco Journal: J Neural Eng Date: 2019-11-12 Impact factor: 5.379
Authors: Steven Baldassano; Xuelong Zhao; Benjamin Brinkmann; Vaclav Kremen; John Bernabei; Mark Cook; Timothy Denison; Gregory Worrell; Brian Litt Journal: J Neural Eng Date: 2018-12-18 Impact factor: 5.379