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Background: Using machine learning to combine wrist accelerometer (ACM) and electrodermal activity (EDA) has been shown effective to detect primarily and secondarily generalized tonic-clonic seizures, here termed as convulsive seizures (CS). A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm. Here we present its performance on pediatric and adult patients in epilepsy monitoring units (EMUs). Methods: Patients diagnosed with epilepsy participated in a prospective multi-center clinical study. Three board-certified neurologists independently labeled CS from video-EEG. The Detection Algorithm was evaluated in terms of Sensitivity and false alarm rate per 24 h-worn (FAR) on all the data and on only periods of rest. Performance were analyzed also applying the Detection Algorithm offline, with a less sensitive but more specific parameters configuration ("Active mode"). Results: Data from 152 patients (429 days) were used for performance evaluation (85 pediatric aged 6-20 years, and 67 adult aged 21-63 years). Thirty-six patients (18 pediatric) experienced a total of 66 CS (35 pediatric). The Sensitivity (corrected for clustered data) was 0.92, with a 95% confidence interval (CI) of [0.85-1.00] for the pediatric population, not significantly different ( p > 0.05) from the adult population's Sensitivity (0.94, CI: [0.89-1.00]). The FAR on the pediatric population was 1.26 (CI: [0.87-1.73]), higher ( p < 0.001) than in the adult population (0.57, CI: [0.36-0.81]). Using the Active mode, the FAR decreased by 68% while reducing Sensitivity to 0.95 across the population. During rest periods, the FAR's were 0 for all patients, lower than during activity periods ( p < 0.001). Conclusions: Performance complies with FDA's requirements of a lower bound of CI for Sensitivity higher than 0.7 and of a FAR lower than 2, for both age groups. The pediatric FAR was higher than the adult FAR, likely due to higher pediatric activity. The high Sensitivity and precision (having no false alarms) during sleep might help mitigate SUDEP risk by summoning caregiver intervention. The Active mode may be advantageous for some patients, reducing the impact of the FAR on daily life. Future work will examine the performance and usability outside of EMUs., Competing Interests: FO, GR, and CC are shareholders of Empatica Inc., which manufactured two of the devices used in this work and developed the two new algorithms tested in this work. GR is also an employee of Empatica and RP is also a consultant and chairs the board of directors for Empatica. TL is part of pending patent applications to detect and predict seizures and to diagnose epilepsy with devices different from the ones used in this work and has received research support from Empatica to conduct this research. TL, WL, and AB have received sensors from Empatica to perform the reported research. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Onorati, Regalia, Caborni, LaFrance, Blum, Bidwell, De Liso, El Atrache, Loddenkemper, Mohammadpour-Touserkani, Sarkis, Friedman, Jeschke and Picard.)

Wearable automated seizure detection devices offer a high potential to improve seizure management, through continuous ambulatory monitoring, accurate seizure counts, and real-time alerts for prompt intervention. More importantly, these devices can be a life-saving help for people with a higher risk of sudden unexpected death in epilepsy (SUDEP), especially in case of generalized tonic-clonic seizures (GTCS). The Embrace and E4 wristbands (Empatica) are the first commercially available multimodal wristbands that were designed to sense the physiological hallmarks of ongoing GTCS: while Embrace only embeds a machine learning-based detection algorithm, both E4 and Embrace devices are equipped with motion (accelerometers, ACC) and electrodermal activity (EDA) sensors and both the devices received medical clearance (E4 from EU CE, Embrace from EU CE and US FDA). The aim of this contribution is to provide updated evidence of the effectiveness of GTCS detection and monitoring relying on the combination of ACM and EDA sensors. A machine learning algorithm able to recognize ACC and EDA signatures of GTCS-like events has been developed on E4 data, labeled using gold-standard video-EEG examined by epileptologists in clinical centers, and has undergone continuous improvement. While keeping an elevated sensitivity to GTCS (92-100%), algorithm improvements and growing data availability led to lower false alarm rate (FAR) from the initial ˜2 down to 0.2-1 false alarms per day, as showed by retrospective and prospective analyses in inpatient settings. Algorithm adjustment to better discriminate real-life physical activities from GTCS, has brought the initial FAR of ˜6 on outpatient real life settings, down to values comparable to best-case clinical settings (FAR < 0.5), with comparable sensitivity. Moreover, using multimodal sensing, it has been possible not only to detect GTCS but also to quantify seizure-induced autonomic dysfunction, based on automatic features of abnormal motion and EDA. The latter biosignal correlates with the duration of post-ictal generalized EEG suppression, a biomarker observed in 100% of monitored SUDEP cases., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: Common data elements (CDEs) are currently unavailable for mobile health (mHealth) in epilepsy devices and related applications. As a result, despite expansive growth of new digital services for people with epilepsy, information collected is often not interoperable or directly comparable. We aim to correct this problem through development of industry-wide standards for mHealth epilepsy data., Methods: Using a group of stakeholders from industry, academia, and patient advocacy organizations, we offer a consensus statement for the elements that may facilitate communication among different systems., Results: A consensus statement is presented for epilepsy mHealth CDEs., Significance: Although it is not exclusive, we believe that the use of a minimal common information denominator, specifically these CDEs, will promote innovation, accelerate scientific discovery, and enhance clinical usage across applications and devices in the epilepsy mHealth space. As a consequence, people with epilepsy will have greater flexibility and ultimately more powerful tools to improve their lives., (Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.)

Objective: New devices are needed for monitoring seizures, especially those associated with sudden unexpected death in epilepsy (SUDEP). They must be unobtrusive and automated, and provide false alarm rates (FARs) bearable in everyday life. This study quantifies the performance of new multimodal wrist-worn convulsive seizure detectors., Methods: Hand-annotated video-electroencephalographic seizure events were collected from 69 patients at six clinical sites. Three different wristbands were used to record electrodermal activity (EDA) and accelerometer (ACM) signals, obtaining 5,928 h of data, including 55 convulsive epileptic seizures (six focal tonic-clonic seizures and 49 focal to bilateral tonic-clonic seizures) from 22 patients. Recordings were analyzed offline to train and test two new machine learning classifiers and a published classifier based on EDA and ACM. Moreover, wristband data were analyzed to estimate seizure-motion duration and autonomic responses., Results: The two novel classifiers consistently outperformed the previous detector. The most efficient (Classifier III) yielded sensitivity of 94.55%, and an FAR of 0.2 events/day. No nocturnal seizures were missed. Most patients had <1 false alarm every 4 days, with an FAR below their seizure frequency. When increasing the sensitivity to 100% (no missed seizures), the FAR is up to 13 times lower than with the previous detector. Furthermore, all detections occurred before the seizure ended, providing reasonable latency (median = 29.3 s, range = 14.8-151 s). Automatically estimated seizure durations were correlated with true durations, enabling reliable annotations. Finally, EDA measurements confirmed the presence of postictal autonomic dysfunction, exhibiting a significant rise in 73% of the convulsive seizures., Significance: The proposed multimodal wrist-worn convulsive seizure detectors provide seizure counts that are more accurate than previous automated detectors and typical patient self-reports, while maintaining a tolerable FAR for ambulatory monitoring. Furthermore, the multimodal system provides an objective description of motor behavior and autonomic dysfunction, aimed at enriching seizure characterization, with potential utility for SUDEP warning., (Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.)

Purpose: StereoElectroEncephaloGraphy (SEEG) is done to identify the epileptogenic zone of the brain using several multi-lead electrodes whose positions in the brain are pre-operatively defined. Intracranial hemorrhages due to disruption of blood vessels can cause major complications of this procedure ([Formula: see text]1%). In order to increase the intervention safety, we developed and tested planning tools to assist neurosurgeons in choosing the best trajectory configuration., Methods: An automated planning method was developed that maximizes the distance of the electrode from the vessels and avoids the sulci as entry points. The angle of the guiding screws is optimized to reduce positioning error. The planner was quantitatively and qualitatively compared with manually computed trajectories on 26 electrodes planned for three patients undergoing SEEG by four neurosurgeons. Quantitative comparison was performed computing for each trajectory using (a) the Euclidean distance from the closest vessel and (b) the incidence angle., Results: Quantitative evaluation shows that automatic planned trajectories are safer in terms of distance from the closest vessel with respect to manually planned trajectories. Qualitative evaluation performed by four neurosurgeons showed that the automatically computed trajectories would have been preferred to manually computed ones in 30% of the cases and were judged good or acceptable in about 86% of the cases. A significant reduction in time required for planning was observed with the automated system (approximately 1/10)., Conclusion: The automatic SEEG electrode planner satisfied the essential clinical requirements, by providing safe trajectories in an efficient timeframe.

FreeSurfer software package automatically estimates the cerebral cortical thickness. Its use is widely accepted, albeit this tool was validated against histologic measurements in only two post-mortem isolated brain MR scans. Indeed, a comparison between histologic measurements and FreeSurfer estimation from in vivo data was never performed. At the "Claudio Munari" Center for Epilepsy and Parkinson Surgery we have included FreeSurfer in our presurgical workflow since 2008, mainly because the automatic reconstruction of the brain surface is useful for carefully planning the surgical resection. We therefore compared cortical thickness values obtained by the automatic software pipeline with manual histologic measurements performed on 27 histologic specimens resected from the corresponding brain regions of the same epileptic subjects. This method-comparison study, including Passing-Bablok regression and Bland-Altman plot analysis, showed a good agreement between FreeSurfer estimation and histologic measurements of cortical thickness. The mean cortical thickness values (±Standard Deviation) obtained with FreeSurfer and histologic measurements were 3.65 mm ± 0.44 and 3.72 mm ± 0.36, respectively (P value = 0.32). Our findings strengthen previous reports on cortical thickness changes as biomarkers of different neurological conditions.

In StereoElectroEncephaloGraphy (SEEG) procedures, intracerebral electrodes are implanted in order to identify the epileptogenic zone in drug-resistant epileptic patients. This paper presents an automatic multitrajectory planner that computes the best trajectory in terms of distance from vessels and guiding screws angle, once the candidate entry and target regions are quickly and roughly defined. The planning process is designed also to spare some brain structures, such as cella media and trigone of the lateral ventricles and brain stem. The planner was retrospectively evaluated on 15 patients who had previously undergone SEEG investigation. Quantitative comparison was performed computing for each patient and for each electrode trajectory 1) the Euclidean distance from the closest vessel; 2) the trajectory incidence angle (guiding screws angle); and 3) the sulcality value. The automatic planner proved to satisfy the clinical requirements, planning safe trajectories in a clinical-compatible timeframe. Qualitative evaluation performed by three neurosurgeons showed that the automatically computed trajectories would have been accepted by them.

Background: Stereoelectroencephalography (SEEG) methodology, originally developed by Talairach and Bancaud, is progressively gaining popularity for the presurgical invasive evaluation of drug-resistant epilepsies., Objective: To describe recent SEEG methodological implementations carried out in our center, to evaluate safety, and to analyze in vivo application accuracy in a consecutive series of 500 procedures with a total of 6496 implanted electrodes., Methods: Four hundred nineteen procedures were performed with the traditional 2-step surgical workflow, which was modified for the subsequent 81 procedures. The new workflow entailed acquisition of brain 3-dimensional angiography and magnetic resonance imaging in frameless and markerless conditions, advanced multimodal planning, and robot-assisted implantation. Quantitative analysis for in vivo entry point and target point localization error was performed on a sub--data set of 118 procedures (1567 electrodes)., Results: The methodology allowed successful implantation in all cases. Major complication rate was 12 of 500 (2.4%), including 1 death for indirect morbidity. Median entry point localization error was 1.43 mm (interquartile range, 0.91-2.21 mm) with the traditional workflow and 0.78 mm (interquartile range, 0.49-1.08 mm) with the new one (P < 2.2 × 10). Median target point localization errors were 2.69 mm (interquartile range, 1.89-3.67 mm) and 1.77 mm (interquartile range, 1.25-2.51 mm; P < 2.2 × 10), respectively., Conclusion: SEEG is a safe and accurate procedure for the invasive assessment of the epileptogenic zone. Traditional Talairach methodology, implemented by multimodal planning and robot-assisted surgery, allows direct electrical recording from superficial and deep-seated brain structures, providing essential information in the most complex cases of drug-resistant epilepsy.

Purpose: The aim of this study was to assess whether the pancreatic phase may replace the arterial phase in the evaluation of endocrine pancreatic tumours., Materials and Methods: Twenty-nine endocrine pancreatic lesions with definitive morphological and immunohistochemical characterisation after surgical treatment (n=24) or fine-needle-aspiration cytology under endoscopic ultrasonography guidance (n=5) were retrospectively evaluated. All lesions were studied with triple-phase 16-row multidetector computed tomography (MDCT). Images obtained during each phase were separately interpreted by two senior radiologists experienced in pancreatic pathology and who were blinded to surgical results. Endocrine tumour and normal pancreas attenuation and the mean absolute tumour-to-gland attenuation difference were measured in each phase, and data were analysed with Student's t test. Visualisation of arterial vascular abnormalities and hypervascular liver metastases in the arterial and pancreatic phases and the diagnostic contribution of the two phases were compared., Results: For both radiologists, the mean absolute tumour-to-gland attenuation difference was significantly higher (p<0.05) in the pancreatic phase (40+/-53 HU and 34+/-56 HU) than in the arterial phase (31+/-38 HU and 26+/-43 HU). There were no differences in the detection of arterial vascular abnormalities or hypervascular liver metastases in the two phases. The diagnostic contribution was higher in the pancreatic phase., Conclusions: In our experience, the pancreatic phase can replace the arterial phase in the evaluation of pancreatic endocrine tumours.