RESUMEN
Introduction: Epilepsy surgery is the only curative treatment for patients with drug-resistant focal epilepsy. Stereoelectroencephalography (SEEG) is the gold standard to delineate the seizure-onset zone (SOZ). However, up to 40% of patients are subsequently not operated as no focal non-eloquent SOZ can be identified. The 5-SENSE Score is a 5-point score to predict whether a focal SOZ is likely to be identified by SEEG. This study aims to validate the 5-SENSE Score, improve score performance by incorporating auxiliary diagnostic methods and evaluate its concordance with expert decisions. Methods and analysis: Non-interventional, observational, multicentre, prospective study including 200 patients with drug-resistant epilepsy aged ≥15 years undergoing SEEG for identification of a focal SOZ and 200 controls at 22 epilepsy surgery centres worldwide. The primary objective is to assess the diagnostic accuracy and generalisability of the 5-SENSE in predicting focality in SEEG in a prospective cohort. Secondary objectives are to optimise score performance by incorporating auxiliary diagnostic methods and to analyse concordance of the 5-SENSE Score with the expert decisions made in the multidisciplinary team discussion. Ethics and dissemination: Prospective multicentre validation of the 5-SENSE score may lead to its implementation into clinical practice to assist clinicians in the difficult decision of whether to proceed with implantation. This study will be conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2014). We plan to publish the study results in a peer-reviewed full-length original article and present its findings at scientific conferences. Trial registration number: NCT06138808.
RESUMEN
BACKGROUND: The safety of performing magnetic resonance imaging (MRI) in patients with spinal cord stimulation (SCS) systems needs to be documented. A prospective in vivo study in patients with SCS, exploring the changes produced by MRI and the associated side effects, was performed. METHODS: After ethics committee approval and patient consent, 31 consecutive patients with SCS at different spinal levels requiring a scheduled MRI evaluation were studied during an 18-month period. All MRIs were performed with a 1.5-T clinical use magnet and a specific absorption rate of no more than 0.9 W/kg. Frequency tables were used for the descriptive study, whereas comparative evaluations were made with the chi-square test for qualitative variables and single-factor analysis of variance for quantitative variables. RESULTS: The mean patient age was 49 +/- 9.5 yr; 67.7% were women (n = 21), and 32.3% were men (n = 10). None of the patients experienced hemodynamic, respiratory, or neurologic alterations. Reported changes were as follows: increased temperature in the generator's area (n = 2, 6.5%); increased in the intensity of the stimulation (n = 1, 3.2%); impedance greater than 4,000 Omega on several of the electrodes in the leads (n = 1, 3.2%); telemetry not possible (n = 2, 6.5%). Radiologic evaluation after MRI revealed no spatial displacements of the SCS leads in any case. CONCLUSION: Under the conditions of the described protocol, MRI in patients with SCS systems resulted in few complications. None of the recorded problems were serious, and in no case were patients harmed or the systems reprogrammed. Maximum patient satisfaction was reported in all cases.
