Barbara C Jobst1, Ritu Kapur2, Gregory L Barkley3, Carl W Bazil4, Michel J Berg5, Gregory K Bergey6, Jane G Boggs7, Sydney S Cash8, Andrew J Cole8, Michael S Duchowny9, Robert B Duckrow10, Jonathan C Edwards11, Stephan Eisenschenk12, A James Fessler5, Nathan B Fountain13, Eric B Geller14, Alica M Goldman15, Robert R Goodman16, Robert E Gross17, Ryder P Gwinn18, Christianne Heck19, Aamr A Herekar20, Lawrence J Hirsch10, David King-Stephens21, Douglas R Labar22, W R Marsh23, Kimford J Meador24, Ian Miller9, Eli M Mizrahi15, Anthony M Murro25, Dileep R Nair26, Katherine H Noe27, Piotr W Olejniczak28, Yong D Park25, Paul Rutecki29, Vicenta Salanova30, Raj D Sheth31, Christopher Skidmore32, Michael C Smith33, David C Spencer34, Shraddha Srinivasan4, William Tatum35, Paul Van Ness15, David G Vossler36, Robert E Wharen35, Gregory A Worrell23, Daniel Yoshor15, Richard S Zimmerman27, Tara L Skarpaas2, Martha J Morrell2,24. 1. Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, U.S.A. 2. NeuroPace, Inc., Mountain View, California, U.S.A. 3. Henry Ford Hospital, Detroit, Michigan, U.S.A. 4. Columbia University Medical Center, New York, New York, U.S.A. 5. University of Rochester Medical Center, Rochester, New York, U.S.A. 6. Johns Hopkins Medicine, Baltimore, Maryland, U.S.A. 7. Wake Forest University Health Sciences, Winston-Salem, North Carolina, U.S.A. 8. Massachusetts General Hospital, Boston, Massachusetts, U.S.A. 9. Miami Children's Hospital / Nicklaus Children's Hospital, Miami, Florida, U.S.A. 10. Yale University 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, Gainesville, Florida, U.S.A. 13. University of Virginia School of Medicine, Charlottesville, Virginia, U.S.A. 14. Institute of Neurology and Neurosurgery at Saint Barnabas, Livingston, New Jersey, U.S.A. 15. Baylor College of Medicine, Houston, Texas, U.S.A. 16. Saint Luke's Hospital, New York, New York, U.S.A. 17. Emory University School of Medicine, Atlanta, Georgia, U.S.A. 18. Swedish Neuroscience Institute, Seattle, Washington, U.S.A. 19. Keck School of Medicine of USC, Los Angeles, California, U.S.A. 20. Via Christi Epilepsy Center, Wichita, Kansas, U.S.A. 21. California Pacific Medical Center, San Francisco, California, U.S.A. 22. Weill Cornell Medical College, New York, New York, U.S.A. 23. Mayo Clinic Minnesota, Rochester, Minnesota, U.S.A. 24. Stanford University, Stanford, California, U.S.A. 25. Augusta University, Augusta, Georgia, U.S.A. 26. Cleveland Clinic Foundation, Cleveland, Ohio, U.S.A. 27. Mayo Clinic Arizona, Scottsdale, Arizona, U.S.A. 28. Louisiana State University, New Orleans, Louisiana, U.S.A. 29. University of Wisconsin Hospital and Clinics, Madison, Wisconsin, U.S.A. 30. Indiana University School of Medicine, Indianapolis, Indiana, U.S.A. 31. Nemours Foundation, Jacksonville, Florida, U.S.A. 32. Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A. 33. Rush University Medical Center, Chicago, Illinois, U.S.A. 34. Oregon Health & Science University, Portland, Oregon, U.S.A. 35. Mayo Clinic's Campus in Florida, Jacksonville, Florida, U.S.A. 36. Valley Neuroscience Institute, Renton, Washington, U.S.A.
Abstract
OBJECTIVE: Evaluate the seizure-reduction response and safety of brain-responsive stimulation in adults with medically intractable partial-onset seizures of neocortical origin. METHODS:Patients with partial seizures of neocortical origin 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. Additional analyses considered safety and seizure reduction according to lobe and functional area (e.g., eloquent cortex) of seizure onset. RESULTS: There were 126 patients with seizures of neocortical onset. The average follow-up was 6.1 implant years. The median percent seizure reduction was 70% in patients with frontal and parietal seizure onsets, 58% in those with temporal neocortical onsets, and 51% in those with multilobar onsets (last observation carried forward [LOCF] analysis). Twenty-six percent of patients experienced at least one seizure-free period of 6 months or longer and 14% experienced at least one seizure-free period of 1 year or longer. Patients with lesions on magnetic resonance imaging (MRI; 77% reduction, LOCF) and those with normal MRI findings (45% reduction, LOCF) benefitted, although the treatment response was more robust in patients with an MRI lesion (p = 0.02, generalized estimating equation [GEE]). There were no differences in the seizure reduction in patients with and without prior epilepsy surgery or vagus nerve stimulation. Stimulation parameters used for treatment did not cause acute or chronic neurologic deficits, even in eloquent cortical areas. The rates of infection (0.017 per patient implant year) and perioperative hemorrhage (0.8%) were 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 adults with seizures of neocortical onset, and those with onsets from eloquent cortex.
RCT Entities:
OBJECTIVE: Evaluate the seizure-reduction response and safety of brain-responsive stimulation in adults with medically intractable partial-onset seizures of neocortical origin. METHODS:Patients with partial seizures of neocortical origin 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. Additional analyses considered safety and seizure reduction according to lobe and functional area (e.g., eloquent cortex) of seizure onset. RESULTS: There were 126 patients with seizures of neocortical onset. The average follow-up was 6.1 implant years. The median percent seizure reduction was 70% in patients with frontal and parietal seizure onsets, 58% in those with temporal neocortical onsets, and 51% in those with multilobar onsets (last observation carried forward [LOCF] analysis). Twenty-six percent of patients experienced at least one seizure-free period of 6 months or longer and 14% experienced at least one seizure-free period of 1 year or longer. Patients with lesions on magnetic resonance imaging (MRI; 77% reduction, LOCF) and those with normal MRI findings (45% reduction, LOCF) benefitted, although the treatment response was more robust in patients with an MRI lesion (p = 0.02, generalized estimating equation [GEE]). There were no differences in the seizure reduction in patients with and without prior epilepsy surgery or vagus nerve stimulation. Stimulation parameters used for treatment did not cause acute or chronic neurologic deficits, even in eloquent cortical areas. The rates of infection (0.017 per patient implant year) and perioperative hemorrhage (0.8%) were 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 adults with seizures of neocortical onset, and those with onsets from eloquent cortex.
Authors: Stephen Meisenhelter; Markus E Testorf; Mark A Gorenstein; Nicholas R Hasulak; Thomas K Tcheng; Joshua P Aronson; Barbara C Jobst Journal: J Neurosci Methods Date: 2018-09-26 Impact factor: 2.390
Authors: Nathaniel D Sisterson; Thomas A Wozny; Vasileios Kokkinos; Alexander Constantino; R Mark Richardson Journal: Neurotherapeutics Date: 2019-01 Impact factor: 7.620
Authors: Marc G Leguia; Ralph G Andrzejak; Christian Rummel; Joline M Fan; Emily A Mirro; Thomas K Tcheng; Vikram R Rao; Maxime O Baud Journal: JAMA Neurol Date: 2021-04-01 Impact factor: 18.302
Authors: Andres M Lozano; Nir Lipsman; Hagai Bergman; Peter Brown; Stephan Chabardes; Jin Woo Chang; Keith Matthews; Cameron C McIntyre; Thomas E Schlaepfer; Michael Schulder; Yasin Temel; Jens Volkmann; Joachim K Krauss Journal: Nat Rev Neurol Date: 2019-03 Impact factor: 42.937