Accès ouvert
2026
article
OpenAlex
Utku Uysal, Patrick Landazuri, David E. Burdette, Sanjay Patra et autres
OBJECTIVE: This study was undertaken to evaluate the safety and effectiveness of responsive thalamic stimulation as adjunctive therapy for drug-resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures (GTCSs). METHODS: NAUTILUS is a prospective, multicenter, single-blind, randomized sham-controlled pivotal trial. Patients were …
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Accès ouvert
2026
article
OpenAlex
Dawn Eliashiv, Vikram R. Rao, Barbara C. Jobst, Jerzy P. Szaflarski et autres
BACKGROUND AND OBJECTIVES: Neuromodulation therapies are approved for the treatment of focal epilepsy based on data from randomized controlled trials (RCTs). After approval of a responsive direct brain stimulation device (The RNS System for focal epilepsy), the Food and Drug Administration required …
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Accès ouvert
2024
article
OpenAlex
Cornelia Natasha Drees, Pegah Afra, Ryan S. Verner, Lesley C. Kaye et autres
BACKGROUND: Vagus nerve stimulation (VNS) at low frequencies (≤30 Hz) has been an established treatment for drug-resistant epilepsy (DRE) for over 25 years. OBJECTIVE: To examine the initial safety and efficacy performance of an investigational, high-frequency (≥250 Hz) VNS paradigm herein called …
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2023
article
OpenAlex
Cornelia Natasha Drees, Mesha‐Gay Brown, Danielle McDermott, Lesley C. Kaye et autres
We assessed the clinical impact of Microburst-VNS in an early feasibility study.
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2022
article
OpenAlex
Lesley C. Kaye, Zoe A. Poolos, John W. Miller, Nicholas P. Poolos
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