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ABSTRACT BACKGROUND: Robot-assisted stereoelectroencephalography (SEEG) may represent a simplified, precise, and safe alternative to the more traditional SEEG techniques. OBJECTIVE: To report our clinical experience with robotic SEEG implantation and to define its utility in the management of patients with medically refractory epilepsy. METHODS: The prospective observational analyses included all patients with medically refractory focal epilepsy who underwent robot-assisted stereotactic placement of depth electrodes for extraoperative brain monitoring between November 2009 and May 2013. Technical nuances of the robotic implantation technique are presented, as well as an analysis of demographics, time of planning and procedure, seizure outcome, in vivo accuracy, and procedure-related complications. RESULTS: One hundred patients underwent 101 robot-assisted SEEG procedures. Their mean age was 33.2 years. In total, 1245 depth electrodes were implanted. On average, 12.5 electrodes were implanted per patient. The time of implantation planning was 30 minutes on average (range, 15-60 minutes). The average operative time was 130 minutes (range, 45-160 minutes). In vivo accuracy (calculated in 500 trajectories) demonstrated a median entry point error of 1.2 mm (interquartile range, 0.78-1.83 mm) and a median target point error of 1.7 mm (interquartile range, 1.20-2.30 mm). Of the group of patients who underwent resective surgery (68 patients), 45 (66.2%) gained seizure freedom status. Mean follow-up was 18 months. The total complication rate was 4%. CONCLUSION: The robotic SEEG technique and method were demonstrated to be safe, accurate, and efficient in anatomically defining the epileptogenic zone and subsequently promoting sustained seizure freedom status in patients with difficult-to-localize seizures.

Epilepsy affects approximately 70 million people globally, with around 20-30% of these individuals experiencing drug-resistant epilepsy in which seizures remain uncontrolled despite prolonged treatment with anti-seizure medications (ASMs). Such refractory epilepsy significantly impairs quality of life, often necessitating surgical resection of the epileptic focus when ASMs fail. Accurate localization of the epileptic focus is crucial for successful surgery and typically requires invasive intracranial monitoring through subdural electrodes (SDE) or stereotactic electroencephalography (SEEG). Despite their effectiveness, the invasiveness of these methods poses significant risks. In response to these challenges, the EP-01 device has been developed to measure intracranial electroencephalogram (EEG) via the cerebral veins, offering a less invasive alternative. The Endovascular EEG Device Prospective Multicenter Single-arm clinical trial to confirm efficacy and safety performance on patients with Intractable Epilepsy (EPSILON IE) trial aims to evaluate the efficacy and safety of EP-01 in diagnosing the lateralization of epileptic foci in patients with focal epilepsy. The hypothesis is that EP-01, when equipped with multiple endovascular EEG electrodes, can accurately diagnose lateralization, reducing the need for more invasive procedures like SDE and SEEG. This multicenter, prospective, single-arm validation clinical trial is set to take place from March 2024 to August 2025, with follow-up extending to August 2026. The study will enroll 37 patients with refractory focal epilepsy across several Japanese medical institutions. Eligibility criteria include age 15-70 years and a vascular anatomy that allows the EP-01 to be guided into cerebral veins close to the epileptic focus. The EP-01 device will be inserted via the jugular veins, with electrodes positioned in target cerebral veins to record intracranial EEG data. The primary endpoint is the percentage agreement in lateralization diagnosis between EP-01 and conventional intracranial electrodes. Secondary endpoints include the diagnostic performance of EP-01, safety assessments, and seizure outcomes one year after resection surgery. Participants will undergo a screening period of 30 days, followed by the clinical trial period of up to two weeks, during which EP-01 will be inserted and monitored. A post-observation period of one week will follow device removal to assess potential adverse events. Data collection will involve EEG recordings, imaging studies, and safety evaluations, with results analyzed to determine the efficacy and safety of the device compared to traditional methods. This trial aims to provide critical data on the potential for EP-01 to serve as a less-invasive, effective alternative for diagnosing epileptic focus lateralization, potentially reducing the need for traditional invasive monitoring methods.

Stereoelectroencephalography (SEEG) methodology, originally developed by Talairach and Bancaud, is progressively gaining popularity for the presurgical invasive evaluation of drug-resistant epilepsies. 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. 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). 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. 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.

BackgroundPost-traumatic epilepsy (PTE) is a severe complication of traumatic brain injury (TBI). Electroencephalography aids early post-traumatic seizure diagnosis, but its optimal utility for PTE prediction remains unknown. We aim to evaluate the contribution of quantitative electroencephalograms to predict first-year PTE (PTE1).MethodsWe performed a multicentre, retrospective case–control study of patients with TBI. 63 PTE1 patients were matched with 63 non-PTE1 patients by admission Glasgow Coma Scale score, age and sex. We evaluated the association of quantitative electroencephalography features with PTE1 using logistic regressions and examined their predictive value relative to TBI mechanism and CT abnormalities.ResultsIn the matched cohort (n=126), greater epileptiform burden, suppression burden and beta variability were associated with 4.6 times higher PTE1 risk based on multivariable logistic regression analysis (area under the receiver operating characteristic curve, AUC (95% CI) 0.69 (0.60 to 0.78)). Among 116 (92%) patients with available CT reports, adding quantitative electroencephalography features to a combined mechanism and CT model improved performance (AUC (95% CI), 0.71 (0.61 to 0.80) vs 0.61 (0.51 to 0.72)).ConclusionsEpileptiform and spectral characteristics enhance covariates identified on TBI admission and CT abnormalities in PTE1 prediction. Future trials should incorporate quantitative electroencephalography features to validate this enhancement of PTE risk stratification models.

Electroencephalographic (EEG) abnormalities are greater in mild cognitive impairment (MCI) with Lewy bodies (MCI-LB) than in MCI due to Alzheimer’s disease (MCI-AD) and may anticipate the onset of dementia. We aimed to assess whether quantitative EEG (qEEG) slowing would predict a higher annual hazard of dementia in MCI across these etiologies. MCI patients (n = 92) and healthy comparators (n = 31) provided qEEG recording and underwent longitudinal clinical and cognitive follow-up. Associations between qEEG slowing, measured by increased theta/alpha ratio, and clinical progression from MCI to dementia were estimated with a multistate transition model to account for death as a competing risk, while controlling for age, cognitive function, and etiology classified by an expert consensus panel. Over a mean follow-up of 1.5 years (SD = 0.5), 14 cases of incident dementia and 5 deaths were observed. Increased theta/alpha ratio on qEEG was associated with increased annual hazard of dementia (hazard ratio = 1.84, 95% CI: 1.01–3.35). This extends previous findings that MCI-LB features early functional changes, showing that qEEG slowing may anticipate the onset of dementia in prospectively identified MCI.

Electrophysiological recordings in animals constitute frequently applied techniques to study neuronal function. In this context, several authors described tethered recordings as a semi-restraint situation with negative implications for animal welfare and suggested radiotelemetric setups as a refinement measure. Thus, we here investigated the hypothesis that tethered recordings exert measurable effects on behavioral and sleep patterns in Sprague–Dawley rats. Animals were kept in monitoring glass cages either with or without a head connection to a recording cable. Saccharin preference, nest building, serum corticosterone and fecal corticosterone metabolite levels were in a comparable range in both groups. The proportion of vigilance states was not affected by the cable connection. Minor group differences were detected in bout lengths distributions, with a trend for longer NREM and WAKE stages in animals with a cable connection. However, a relevant effect was not further confirmed by an analysis of the number of sleep/wake and wake/sleep transitions. The analysis of activity levels did not reveal group differences. However, prolonged exposure to the tethered condition resulted in an intra-group increase of activity. In conclusion, the comparison between freely moving vs tethered rats did not reveal major group differences. Our findings indicate that telemetric recordings only offer small advantages vs cabled set ups, though this may differ in other experimental studies where for example anxiety- or drug-induced effects are analyzed.

Excessive daytime sleepiness (EDS) causes difficulty in concentrating and continuous fatigue during the day. In the clinical setting, the assessment and diagnosis of EDS rely mostly on subjective questionnaires and verbal reports, which compromises the reliability of clinical diagnosis and the ability to robustly discern candidacy for available therapies and track treatment response. In this study, we used a computational pipeline for the automated, rapid, high-throughput, and objective analysis of previously collected encephalography (EEG) data to identify surrogate biomarkers for EDS, thereby defining the quantitative EEG changes in individuals with high Epworth Sleepiness Scale (ESS) (n = 31), compared to a group of individuals with low ESS (n = 41) at the Cleveland Clinic. The epochs of EEG analyzed were extracted from a large overnight polysomnogram registry during the most proximate period of wakefulness. Signal processing of EEG showed significantly different EEG features in the low ESS group compared to high ESS, including enhanced power in the alpha and beta bands and attenuation in the delta and theta bands. Our machine learning (ML) algorithms trained on the binary classification of high vs. low ESS reached an accuracy of 80.2%, precision of 79.2%, recall of 73.8% and specificity of 85.3%. Moreover, we ruled out the effects of confounding clinical variables by evaluating the statistical contribution of these variables on our ML models. These results indicate that EEG data contain information in the form of rhythmic activity that could be leveraged for the quantitative assessment of EDS using ML.

Background Stereoelectroencephalography (SEEG) is an established diagnostic technique for the localization of the epileptogenic zone in drug-resistant epilepsy. In vivo accuracy of SEEG electrode positioning is of paramount importance since higher accuracy may lead to more precise resective surgery, better seizure outcome and reduction of complications. Objective To describe experiences with the SEEG technique in our comprehensive epilepsy center, to illustrate surgical methodology, to evaluate in vivo application accuracy and to consider the diagnostic yield of SEEG implantations. Methods All patients who underwent SEEG implantations between September 2008 and April 2016 were analyzed. Planned electrode trajectories were compared with post-implantation trajectories after fusion of pre- and postoperative imaging. Quantitative analysis of deviation using Euclidean distance and directional errors was performed. Explanatory variables for electrode accuracy were analyzed using linear regression modeling. The surgical methodology, procedure-related complications and diagnostic yield were reported. Results Seventy-six implantations were performed in 71 patients, and a total of 902 electrodes were implanted. Median entry and target point deviations were 1.54 mm and 2.93 mm. Several factors that predicted entry and target point accuracy were identified. The rate of major complications was 2.6%. SEEG led to surgical therapy of various modalities in 53 patients (69.7%). Conclusions This study demonstrated that entry and target point localization errors can be predicted by linear regression models, which can aid in identification of high-risk electrode trajectories and further enhancement of accuracy. SEEG is a reliable technique, as demonstrated by the high accuracy of conventional frame-based implantation methodology and the good diagnostic yield.

Intracranial subdural grid monitoring is a useful diagnostic technique for surgical localization in patients with intractable partial epilepsy. The rationale for the present study was to assess the morbidity of intracranial recordings and the surgical outcomes. We retrospectively reviewed the clinical data for 189 unique patients undergoing 198 intracranial subdural grid monitoring sessions between 1996 and 2004 at a tertiary epilepsy center. The mean age of patients undergoing monitoring was 28 +/- 14 years. An average of 63 +/- 23 electrodes were inserted. The mean duration of monitoring was 8 +/- 4 days. Localization of an epileptogenic zone occurred in 156 sessions (79%) resulting in 136 resections (69%). There were 13 major complications (6.6%), including five infections and six hematomas. Three patients (1.5%) developed permanent deficits related to implantation. Sixty-two (47%) of 136 patients undergoing resection were seizure-free after resection. An additional 38 patients (28%) had a significant reduction in seizures. The mean follow-up was 51 +/- 30 months. The duration of monitoring, bone flap replacement, number of electrodes, and perioperative corticosteroids were not associated with infection or complication. Subdural grid monitoring for identification an epileptogenic focus is high yield, revealing a focus in 79% of monitoring sessions. Complications rarely result in permanent morbidity (1.5%). Surgical outcome indicated that 74% of patients experienced a favorable reduction in seizure tendency.

Invasive electroencephalography recordings with depth or subdural electrodes are necessary to identify the ictogenic area in some drug-resistant focal epilepsies. We aimed to analyze the safety profile of intracranial electrode implantation in a tertiary center and the factors associated with its complications. We retrospectively examined complications in 163 intracranial procedures performed in adult patients. Implantation methods included oblique depth stereotactic approach ( n  = 128) and medial–temporal depth stereotactic approach in combination with subdural strip placement ( n  = 35). 1201 depth macroelectrodes, 59 bundles of microelectrodes (in 30 patients) and 148 subdural electrodes were implanted. Complications were classified as major (requiring treatment or leading to neurological impairment) or minor. The rate of overall complications was 4.9 % ( n  = 8), with 3.1 % ( n  = 5) of major complications, though no permanent morbidity or mortality was recorded. Infection occurred in 1.2 % and hemorrhage in 3.7 % of patients. One hemorrhage occurred for every 225 electrodes implanted (4.4 ‰). Microelectrodes were not responsible for any complications. Overall and hemorrhagic complications were significantly associated with MRI-negative cases (7.3 and 6.3 % versus 0 %, p  = 0.04). We believe that intracranial electrode implantation has a favorable safety profile, without permanent deficit. These risks should be balanced with the benefits of invasive exploration prior to surgery. Furthermore, this study provides preliminary evidence regarding the safety of micro-macroelectrodes.