Citations 2
Responsive stimulation of the thalamus for idiopathic generalized epilepsy: Results of the randomized controlled NAUTILUS trial through 18 months
Uysal, Utku, Landazuri, Patrick , Patra, Sanjay, Crudele, Angela, Englot, Dario, Gavvala, Jay R., Tandon, Nitin, Pati, Sandipan , Kaye, Lesley , Ojemann, Steven, Barnett, Daniel, Neimat, Joseph, Palade, Adriana , Rahimpour, Shervin, Arain, Amir A., Cash, Sydney S., Salanova, Vicenta , Urban, Alexandra, Welch, W. Pete, Gonzalez-Martinez, Jorge A., Spencer, David, Rivera‐Cruz, Angélica , Dugan, Patricia, Fajardo, Marytery , Lallas, Matt, Odom, Nicole, Roland, Jarod L. , Willie, Jon T., Sheth, Sameer A., Skidmore, Christopher T., Drees, Cornelia , Parker, Jonathon, Szaflarski, Jerzy P. , Johnson, Lise, Norman, Jacob F. , Wingeier, Brett, Group, Nautilus Study, Group, Nautilus Study, Englot, Dario J. , Englot, Dario J , Richardson, Robert Mark , Van Gompel, Jamie J , Starnes, Keith , Ernst, Lia D , Amin, Ushtar , Roland, Jarod L , Goldman, Alica M , Wu, Chengyuan , Drees, Cornelia , Ganguly, Taneeta Mindy , Szaflarski, Jerzy , Johnson, Lise , Norman, Jacob F , Landazuri, Patrick , Burdette, David E. , Patra, Sanjay , Gavvala, Jay R. , Tandon, Nitin , Pati, Sandipan Bankim Behari , Kaye, Lesley C , Ojemann, Steven , Neimat, Joseph S. , Rahimpour, Shervin , Arain, Amir M. , Cash, Sydney S. , Urban, Alexandra , González-Martínez, Jorge , Gompel, Jamie J. Van , Ernst, Lia , Dugan, Patricia , Jobst, Barbara C. , Willie, Jon T , Sheth, Sameer A. , Goldman, Alica M. , Skidmore, Christopher , Wu, Chengyuan , Parker, Jonathon J. , Ganguly, Taneeta M. , Ghatan, Saadi , Wingeier, Brett , Seale, Cairn G. , Morrell, Martha J.
Epilepsia | June 3, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
Abstract 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 ≥12 years of age with drug‐resistant IGE and ≥2 GTCSs over a 3‐month baseline. Bilateral depth leads were targeted to the centromedian thalamus. One month later, patients were randomized to Active (responsive stimulation, n = 44) or Sham (no stimulation, n = 43). The effectiveness evaluation period (EEP) began 3 months postimplant through 1 year. After a second GTCS in the EEP, patients transitioned to open‐label active stimulation. The primary safety endpoint was the serious adverse device‐related event (SADE) rate at 84 days postimplant. The primary effectiveness endpoint was time‐to‐second‐GTCS during the EEP. Additional endpoints included median percent change in days with any generalized seizure, GTCS frequency, and responder rate (RR). Results Eighty‐seven patients were implanted across 23 US centers. The SADE rate was significantly below the performance goal (6.9%, p < .0001), with no adverse effects on cognition, mood, or sleep. The prespecified primary effectiveness endpoint was not significant. However, a post hoc mixed‐effects model considering all EEP days demonstrated greater GTCS reduction in the originally randomized Active group (61%) compared to patients originally randomized to Sham (49%, p = .030). Eighteen‐month outcomes included 76.8% median GTCS reduction, 62.5% RR, 40% GTCS‐free at that timepoint, and 77.8% median reduction in days with any generalized seizure. More than 90% of patients and 86% of physicians reported improvement on Global Impression of Change scales. Significance NAUTILUS is the first randomized controlled neuromodulation trial in IGE. Responsive thalamic stimulation provided a clinically meaningful and durable reduction in seizures with an acceptable safety profile, offering a much‐needed option for drug‐resistant IGE.
Pediatric epilepsy surgery: Global survey of referral and presurgical evaluation practices
Ramantani, Georgia , Cross, J. Helen , Cserpán, Dorottya , Ahemad, Emtnan , Aparicio, Javier , Arzimanoglou, Alexis , Barba, Carmen , Bingaman, William , Braun, Kees , Burman, R J, Cai, Lixin , Cao, Dezhi , Caraballo, Roberto , Cloppenborg, Thomas , Cukiert, Cristine Mella , Dal, Sameer , Englot, Dario, Enright, Noelle , Sorbets, Sarah Ferrand , Mahecha, Laura Guio, Hallböök, T , Harvey, A. Simon, Holthausen, H, Jiang, Y , Kannan, Lakshminarayanan , Lallas, Matt, Valappil, Ahsan Moosa Naduvil , Patil, Sandeep Bhagwan , Pieper, Tom , Tripathi, Manjari , Vendégh, Lejla, Weiner, Howard , Wilmshurst, Jo, Smith, MK, Group, ILAE Pediatric Epilepsy Surgery Task Force and Study, Wilmshurst, Jo M. , Burman, Richard J. , Shetty, Jay , Burman, Richard J , Butler, James , Cai, Li-Xin , Cao, Dezhi , Caraballo, Roberto H , Chipaux-Raffo, Mathilde , Cloppenborg, Thomas , Cukiert, Arthur , Dal, Sameer , Englot, Dario J , Enright, Noelle , Fallah, Aria , Ferrand Sorbets, Sarah , Feucht, Martha , Gill, Deepak , Hadjinicolaou, Aristides , Harvey, A Simon , Holthausen, Hans , Jiang, Yuwu , Kannan, Lakshminarayanan , Katlowitz, Kalman A , Kotulska-Jóźwiak, Katarzyna , Kudr, Martin , Lallas, Matt , Patil, Sandeep Bhagwan , Specchio, Nicola , Tripathi, Manjari , Wilmshurst, Jo M , Smith, Mary Lou , Wirrell, Elaine C , Ramantani, Georgia , Cross, Helen J , Shetty, Jay , Barba, Carmen , Braun, Kees P. J. , Englot, Dario J. , Fallah, Aria , Feucht, Martha , Moosa, Ahsan N. , Specchio, Nicola , Wirrell, Elaine
Epilepsia | June 2, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
Abstract Objective Pediatric epilepsy surgery is well established, but contemporary global data on referral and presurgical evaluation practices are lacking. This International League Against Epilepsy (ILAE) Pediatric Epilepsy Surgery Task Force study provides an updated overview of current trends and regional differences. Methods Group‐level data were collected from 61 epilepsy surgery programs (49 pediatric‐only) across 29 countries and six continents, identified through ILAE networks, and included all children and adolescents treated in 2023 who underwent presurgical evaluation/epilepsy surgery. Results Group‐level data were available for 2427 patients. Mean age at surgery was 9.1 ± 4.9 years; mean epilepsy duration was 5.3. At surgery, 3.2% were <1 year old (highest in Oceania: 5.1%), and 6.1% were nonpharmacoresistant (highest in Europe: 15.0%). Prior neurosurgery was reported in 14.2% (highest in North America: 28.8%), including 8.0% resections (6.1% for epilepsy, 1.5% for tumors; highest in Oceania: 16.5%), 2.3% disconnections (1.3% corpus callosotomy; highest in South America: 4.7%), and 4.2% neuromodulation (3.7% vagal nerve stimulation, .2% responsive neurostimulation, one deep brain stimulation; highest in North America: 12.2%). Developmental and epileptic encephalopathies (DEEs) at surgery included Lennox–Gastaut syndrome (7.4%), infantile epileptic spasms syndrome (5.1%), and DEE with spike–wave activation in sleep (1.5%). Presurgical investigations included fluorodeoxyglucose positron emission tomography (52.6%; highest in Oceania: 79.7%), genetic testing (46.8%; highest in Asia: 54.3%), magnetic resonance imaging (MRI) postprocessing (32.4%; highest in South America: 53.0%), functional MRI (fMRI; 15.2%; highest in North America: 40.3%), magnetoencephalography (11.9%; highest in North America: 39.3%), single photon emission computed tomography (9.6%; highest in North America: 22.2%), high‐density electroencephalography (EEG; 1.9%; highest in Europe: 4.7%), source localization (1.6%; highest in Oceania: 7.6%), Wada test (1.2%; highest in North America: 3.5%), and EEG‐fMRI (.5%; highest in Europe: 1.1%). Significance Despite some early surgeries, including in infancy and before pharmacoresistance, mean epilepsy duration before surgery remains >5 years. Reoperations are common, with resection more frequent than neuromodulation. Genetic testing in nearly half of patients reflects its growing relevance, and the high rate of DEEs underscores the complexity of surgical candidates.