Trial Registration Information
seizures, epilepsy, seizure, difficult-to-treat, Thalamus, Epilepsy
EPILEPSY, ADVERSE EVENTS, EPILEPSY, FOCAL EPILEPSY, ANTERIOR
MORE ClinicalTrials.gov Identifier: NCT01521754, first posted on January 31, 2012.Of the 50 million people with epilepsy worldwide, one-third continue to have seizures despite appropriate antiseizure medications (ASMs).The efficacy of DBS of the anterior nucleus of the thalamus (ANT DBS) in patients with DRE was demonstrated in the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTE) pivotal trialTo address these limitations and gain additional experience with ANT DBS, we designed a large multinational registry. The registry permitted patients with difficult-to-treat focal epilepsy and comorbidities to be assessed, with physicians electing to use DBS targeting approaches and leads not evaluated in the prior studies. The primary research questions in this study are as follows: to present (1) the clinical characteristics of the patients, (2) changes in seizure frequency (SF) and health-related quality of life (HRQOL), (3) adverse events (AEs) and (4) stimulation parameters of ANT DBS up to 24 months of follow-up.