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Epilepsia · 2017

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

СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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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

Аннотация

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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты