Focal Onset Seizures Research Articles

A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy

ObjectivePerampanel is a once-daily oral anti-seizure medication for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures (FBTCS), and generalized tonic-clonic seizures. Study 402 (NCT02033902) collected safety information on clinically important treatment-emergent adverse events (TEAEs) from real-world clinical practice in patients aged ≥12 years with refractory epilepsy who were receiving perampanel as an add-on therapy. MethodsStudy 402 was a multicenter, observational, 52-week cohort study conducted in Austria, Belgium, Czech Republic, Denmark, France, Israel, Sweden, and the United Kingdom. Safety data were gathered prospectively from patients at clinic visits. The primary endpoint was the incidence of clinically important TEAEs defined as dizziness; blurred vision; somnolence; aggression; balance disorders (including ataxia and falls); weight gain; suicidality; drug abuse, misuse, dependence, and withdrawal; skin photosensitivity; and unintended pregnancy while taking levonorgestrel-containing contraceptives. Off-label use of perampanel and outcomes associated with any suspected drug–drug interaction were also monitored and recorded. Secondary endpoints included the Hospital Anxiety and Depression Scale (HADS) and Clinical Global Impression of Change. ResultsOf 483 patients in the Safety Analysis Set, mean (standard deviation [SD]) age was 38.3 (15.1) years, 48.4% were female, mean (SD) time since diagnosis was 23 (14.8) years, 56.5% had focal impaired awareness seizures, and 48.7% had FBTCS. Overall, 243 (49.3%) patients treated with perampanel completed the study and 227 (46.0%) patients discontinued. The most common primary reason for discontinuation was adverse events (n = 130 [26.4%]).A total of 301 (62.3%) patients reported at least one TEAE, of which 45 (15.0%) patients had severe TEAEs and 256 (85.0%) patients had TEAEs judged as mild to moderate in severity. Overall, 51 (10.6%) patients had serious TEAEs, including two deaths that were judged as not related to perampanel, and 136 (28.2%) patients experienced a TEAE that led to treatment discontinuation. Clinically important TEAEs were reported by 153 (31.7%) patients, with the most common being dizziness (13.9%), balance disorders (5.6%), aggression (5.4%), and weight gain (5.4%). In general, the frequencies of clinically important TEAEs were lower in this study compared with previous interventional clinical studies, except for the incidence of suicidality (2.1% vs 1.0%) and aggression (5.4% vs 5.1%). Mean total HADS scores were similar at the end of the study compared with baseline; at the end of treatment, most (>60%) patients had no shift in HADS score category; ∼15% of patients moved to a worse category vs baseline and ∼20% of patients moved to an improved category vs baseline for both anxiety and depression. Based on investigator assessment, disease severity was improved in 185/415 (44.6%) patients. A subanalysis in elderly patients aged ≥65 years showed similar results to the overall population. ConclusionsThe data from this observational study are consistent with the known safety profile of perampanel derived from previous interventional phase II and III clinical studies. No unusual or unexpected TEAEs were observed in this real-world clinical practice setting.

Mimicking focal epileptic seizures‐episodic pain due to a facial foreign body in a puppy: Imaging characteristics and treatment

AbstractA 4‐month‐old female entire Cavalier King Charles Spaniel was referred for investigation into a 3‐week history of suspected focal onset seizures, characterised by head nodding and eyelid twitching. An inflammatory soft‐tissue reaction surrounding a suspected foreign body (FB) in the subcutaneous tissue and muscles at the level of the left maxilla in the caudal aspect of the left maxillary second molar was detected using MRI. The presence of the FB was confirmed ultrasonographically. This was found to be a grass seed upon surgical removal. The previously reported clinical signs resolved immediately after the surgery. It was suspected that the FB and secondary inflammatory reaction incited a form of trigeminal neuralgia manifesting as paroxysmal head nodding and facial twitching. A form of trigeminal neuralgia should be included in the differential diagnosis of facial focal motor seizures and should be investigated accordingly before initiating any antiepileptic treatment.

Quality of life study for caregivers of people with uncontrolled focal-onset seizures

Aim The aim of this study was to capture and measure the impact of caregiving for an adult with uncontrolled drug-resistant focal-onset seizures (FOS) on the caregivers’ quality of life (QoL), and to quantify the costs of productivity losses associated with providing informal care in this patient population. Methods An online survey, which included the EQ-5D-5L, CarerQol-7D and the Work Productivity and Activity Impairment: Specific-Health Problem (WPAI:SHP) questionnaires, was administered to caregivers of individuals with uncontrolled drug-resistant FOS in the United Kingdom (UK), France, Spain, Germany, Italy, and Sweden. Results The study included 345 caregivers. Most were males, aged between 25 and 34 years old whose caring responsibilities took between 15 and 24 h per week. The caregivers’ mean EQ-5D-5L score was 0.6, with 95% confidence intervals (CI) of [0.58, 0.63], whilst the mean CarerQol-7D score was 72.61 [70.46, 74.76]. Caregivers’ mental health was the most substantially affected aspect of their QoL. In addition, most caregivers reported deriving some or a lot of fulfilment out of their caregiving tasks. The WPAI:SHP showed that the mean percentage of work impairment due to caregiving responsibilities was 63%, [59.75, 66.26]. The mean annualised costs of productivity losses per caregiver were estimated at €14,872 [€11,908; €17,888]. Limitations One limitation consisted in the use of an online survey instead of a face-to-face interview. However, the medical terms were clearly explained, and examples were provided to help participants to give accurate responses. Another limitation was that the respondents self-reported as caregivers. Efforts were made to mitigate this weakness by using screener questions. Conclusion This study found that providing informal care for people with uncontrolled drug-resistant FOS had a negative impact on caregivers’ QoL, with mental health being affected the most. However, caregivers found their role fulfilling and had support with their caring tasks.

PP168 Quality-Of-Life Study For Caregivers Of People With Drug-Resistant Focal Onset Seizures

IntroductionThe quality of life (QoL) of caregivers who look after individuals with drug-resistant focal-onset seizures (FOS) can be significantly affected by their caregiving responsibilities. This is widely recognized by various health technology assessment bodies, including the National Institute for Health and Care Excellence. The aim of this study was to assess the QoL and to generate health-related utility data for individuals caring for adults with drug-resistant FOS. This project will provide critical information on an often neglected and undervalued aspect of epilepsy.MethodsAn online survey including questions on sociodemographic characteristics, caregiver burden and productivity, the EQ-5D-5L, and the Care Related Quality of Life (CarerQol-7D) was administered to caregivers of individuals with drug-resistant FOS in the United Kingdom.ResultsThe analysis included 86 caregivers. The majority were men aged between 25 and 34 years whose caring responsibilities ranged from 25 to 34 hours per week. In the previous 28 days, most individuals they cared for experienced four FOS, with the longest seizure-free period ranging from 6 to 15 days. The patients had previously been prescribed at least four anti-seizure medications.The caregivers’ mean EQ-5D-5L score was 0.66 (range -0.19 to 1), whilst the mean CarerQol-7D score was 71 (range 21 to 100). The most affected dimension of the EQ-5D-5L was self-care, while the most affected dimension of the CarerQol-7D was physical functioning.ConclusionsCaring for people with drug-resistant FOS has a negative impact on the QoL of caregivers, particularly in the domains of self-care and physical functioning.

PP261 Development Of A Mapping Algorithm To Predict SF-6D Values In People With Drug-Resistant Focal Onset Seizures

IntroductionFocal-onset-seizures (FOS) are commonly experienced by individuals with epilepsy and have a significant impact on quality of life (QoL). This study aimed to develop a mapping algorithm to predict the 6 dimension short form questionnaire (SF-6D) values in adults with FOS for use in economic evaluations of a new treatment, cenobamate.MethodsAn online survey, including questions on sociodemographic, disease history, the short form (SF) 36, and an epilepsy-specific measure (quality of life in epilepsy problems questionnaire, QOLIE-31-P) was administered to individuals with drug-resistant FOS in the top 5 EU countries (UK, Spain, Germany, Italy and France). A range of regression models were fitted to SF-6D scores including direct and response mapping approaches.ResultsThe analysis included 361 people. In the previous 28 days, the mean number of FOS experienced was three, (range: 0–43) and longest seizure-free period was 14 days (range: 1–28). Mean responses on all SF-36 dimensions were lower than general population norms. Mean SF-6D and QOLIE-31-P scores were 0.584 and 45.72, respectively. The best performing model was the ordinary least squares (OLS), with root mean squared error (RMSE) and mean absolute error (MAE) values of 0.0977 and 0.0742, respectively. Explanatory variables which best predicted SF-6D included seizure frequency, seizure severity, seizure freedom, and age.ConclusionsPeople with drug-resistant FOS have poor QoL. The mapping algorithm enables the prediction of SF-6D values from clinical outcomes in individuals with drug-resistant FOS. It can be applied to outcome data from clinical trials to facilitate cost-utility analysis.

Neural Conductional Impairment in the Brainstem Auditory Pathway in term Infants with Perinatal Problems

Approximately 30% of epilepsy patients experience recurrent seizures despite many new antiseizure medications (ASMs) became available over the past 25 years. Cenobamate is a newest FDA approved ASM for the treatment of focal onset seizures in adults as both monotherapy and adjunctive therapy in November 2019 [1]. Pivotal clinical trials reported superior seizure improvement in patients with focal epilepsy.

Assessing the landscape of STXBP1-related disorders in 534 individuals.

Disease-causing variants in STXBP1 are among the most common genetic causes of neurodevelopmental disorders. However, the phenotypic spectrum in STXBP1-related disorders is wide and clear correlations between variant type and clinical features have not been observed so far.Here, we harmonized clinical data across 534 individuals with STXBP1-related disorders and analysed 19 973 derived phenotypic terms, including phenotypes of 253 individuals previously unreported in the scientific literature. The overall phenotypic landscape in STXBP1-related disorders is characterized by neurodevelopmental abnormalities in 95% and seizures in 89% of individuals, including focal-onset seizures as the most common seizure type (47%). More than 88% of individuals with STXBP1-related disorders have seizure onset in the first year of life, including neonatal seizure onset in 47%. Individuals with protein-truncating variants and deletions in STXBP1 (n = 261) were almost twice as likely to present with West syndrome and were more phenotypically similar than expected by chance. Five genetic hotspots with recurrent variants were identified in more than 10 individuals, including p.Arg406Cys/His (n = 40), p.Arg292Cys/His/Leu/Pro (n = 30), p.Arg551Cys/Gly/His/Leu (n = 24), p.Pro139Leu (n = 12), and p.Arg190Trp (n = 11). None of the recurrent variants were significantly associated with distinct electroclinical syndromes, single phenotypic features, or showed overall clinical similarity, indicating that the baseline variability in STXBP1-related disorders is too high for discrete phenotypic subgroups to emerge. We then reconstructed the seizure history in 62 individuals with STXBP1-related disorders in detail, retrospectively assigning seizure type and seizure frequency monthly across 4433 time intervals, and retrieved 251 anti-seizure medication prescriptions from the electronic medical records. We demonstrate a dynamic pattern of seizure control and complex interplay with response to specific medications particularly in the first year of life when seizures in STXBP1-related disorders are the most prominent. Adrenocorticotropic hormone and phenobarbital were more likely to initially reduce seizure frequency in infantile spasms and focal seizures compared to other treatment options, while the ketogenic diet was most effective in maintaining seizure freedom.In summary, we demonstrate how the multidimensional spectrum of phenotypic features in STXBP1-related disorders can be assessed using a computational phenotype framework to facilitate the development of future precision-medicine approaches.

Different pharmacoresistance of focal epileptic spasms, generalized epileptic spasms, and generalized epileptic spasms combined with focal seizures.

ObjectiveAmong standard treatments for infantile spasms, adrenocorticotropic hormone (ACTH) is reported as the best treatment, but ACTH is ineffective in one‐half of the patients. To establish precision medicine, we examined pharmacoresistance of focal epileptic spasms (ES), generalized ES, and generalized ES combined with focal seizures, diagnosed based on the revised seizure classification of ILAE in 2017.MethodsWe conducted a retrospective nationwide study in Japan on the long‐term seizure outcome of ES. Long‐term seizure outcome was evaluated by seizure‐free rate, seizure‐free period, and Kaplan‐Meier curve. Seizure‐free was defined as seizure control for longer than 2 months.ResultsFrom the medical history of 501 patients, 325 patients had generalized ES only (GES group) at the start of the first treatment, 125 patients had generalized ES after focal seizure onset (FS‐GES group), seven patients had focal ES after focal seizure onset (FS‐FES group), and 24 patients had generalized ES combined with focal seizures after focal seizure onset (FS‐GES + FS group). Seizure‐free period of ES (generalized ES and focal ES) [mean (95% confidence interval)] was 2.7 (0.0‐5.4) months in GES group, 1.1 (0.1‐2.2) months in FS‐GES group, 1.0 (0.2‐1.9) months in FS‐GES + FS group, and 0.1 (−0.2‐0.5) months in FS‐FES group. Seizure‐free rate, seizure‐free period, and Kaplan‐Meier curve of generalized ES were almost the same in GES group and FS‐GES group, with characteristics of superior response to ACTH. Mean seizure‐free period of generalized ES combined with focal seizures was significantly shorter in FS‐GES + FS group than in GES group. Mean seizure‐free period of focal ES in FS‐FES group was extremely short with exceedingly early relapse.SignificancePharmacoresistance was different in generalized ES, focal ES, and generalized ES combined with focal seizures. ES with focal features or with focal seizures may have focal lesions, thus consider surgical options earlier in the course.

Compromise Between Individual Rationality and Collective Rationality in Decision-Making in Schistocerca Gregaria (The Desert Locust)

Approximately 30% of epilepsy patients experience recurrent seizures despite many new antiseizure medications (ASMs) became available over the past 25 years. Cenobamate is a newest FDA approved ASM for the treatment of focal onset seizures in adults as both monotherapy and adjunctive therapy in November 2019 [1]. Pivotal clinical trials reported superior seizure improvement in patients with focal epilepsy.

Cenobamate: New Antiseizure Medication with High Efficacy

Approximately 30% of epilepsy patients experience recurrent seizures despite many new antiseizure medications (ASMs) became available over the past 25 years. Cenobamate is a newest FDA approved ASM for the treatment of focal onset seizures in adults as both monotherapy and adjunctive therapy in November 2019 [1]. Pivotal clinical trials reported superior seizure improvement in patients with focal epilepsy.

A retrospective, real-world experience of perampanel monotherapy in patient with first new onset focal seizure: A Thailand experience.

ObjectiveReal‐world data on efficacy and tolerability of perampanel (PER) monotherapy in treatment‐naïve patients with focal onset seizures (FOS) and/or focal‐to‐bilateral tonic‐clonic seizures (FBTCS) to assess efficacy effectiveness and tolerability.MethodsThis is a retrospective review of study patients with new FOS with or without FBTCS, aged ≥15 years, who had been prescribed PER as monotherapy. Treatment outcome included retention rate, responder, and seizure‐free rate at observational point 3, 6, and 12 months (OP3, OP6, and OP12). Treatment‐emergent adverse events (TEAEs) and adverse drug reactions were recorded.ResultsA total of 41 patients enrolled in the study (male:female; 17:22, mean age =46.1 ± 21.8 years), with new FOS and/or FBTCS. The proportions of individuals remaining on PER monotherapy at 3, 6, and 12 months were evaluated. The median PER dosage was 4 mg (range 2‐8 mg). The retention rates at OP3, OP6, and OP12 were 88%, 73%, and 61%, respectively. The seizure freedom rates at OP3, OP6, and OP12 were 78%, 80%, and 76%, respectively. About 14% had discontinued the PER monotherapy because of lack of efficacy. Sixteen individuals (41%) had TEAEs; common AEs were dizziness, somnolence, and ataxia; and only one case had depression. The AEs with somnolence and ataxia were found higher in elderly (15% and 30%) than adult patients (7% and 3%), respectively. Only 14% had intolerant adverse events, and it was found higher in elderly (23%).SignificanceReal‐world data of PER monotherapy in treatment‐naïve patients with focal onset seizures demonstrated good effectiveness and a good safety profile at relatively low doses. By starting with low dosage and slow titration of PER help to minimize the impact of adverse effects, maximize adherence, and increase patient retention. PER has a once‐daily dosing schedule that supports patient adherence contributes to achieving seizure freedom.

Olfactory function in patients with temporal lobe epilepsy; correlation of functional magnetic resonance imaging for olfaction with the laterality of the epileptic focus

The olfactory function shares the same cerebral structures as those involved in the origin and propagation of focal temporal lobe seizures. Likewise, functional magnetic resonance imaging (fMRI) allows the study of olfactory function. This suggests that by quantitatively studying the olfactory function with an olfactory paradigm through fMRI it is possible to identify the functional alteration produced by the epileptic focus. The objective of the present study was to assess the olfactory function in the side of the epileptic focus in patients with mesial temporal lobe epilepsy, using fMRI for smell, and propose a non-invasive diagnostic method for patients candidates to mesial temporal lobe epilepsy surgery. MethodsPatients (n = 18) with clinical diagnosis of mesial temporal lobe epilepsy, refractory to pharmacological treatment: 7 patients (38.9%) with non-invasive studies consistent enough to submit them to anterior temporal lobectomy, and 11 (61.1%) patients where focal onset seizures were identified by stereoelectroencephalography (SEEG) on the left temporal lobe in 5 (27.8%) and in both temporal lobes in 2 (11.1%). Patients were evaluated using EEG, MRI, neuropsychological data, and fMRI with olfactory paradigm. Results of the fMRI were compared with the laterality of the epileptic focus determined by intracranial electroencephalogram recordings through stereotactically placed electrodes, and with post-surgical outcome at one year of follow-up. ResultsfMRI showed a lower olfactory activation in 81.8% concordant with unilateral onset seizures. There were significant differences of olfactory fMRI activation between epileptic and non-epileptic foci. ConclusionFunctional magnetic resonance imaging with an olfactory paradigm may be a non-invasive diagnostic tool to determine the laterality of seizure onset in the mesial temporal lobe.

P.103 Midline Spikes and Intractable Seizures in Pediatric Epilepsy

Background: Epileptic discharges localized to the midline vertex are rare. However, they have been associated with intractable seizures and severe long-term consequences in the developing brain. Our study aimed to understand the etiology of pediatric midline seizures and define post-surgical seizure outcomes. Methods: We reviewed charts, electroencephalography (EEG), and neuroimaging studies of ten pediatric patients with epileptic discharges localized to the midline vertex in the Comprehensive Epilepsy Program. The seizures were classified according to the International League Against Epilepsy criteria, patient age, sex, neuroimaging results, seizure etiology and outcomes were obtained. Results: Age of seizure onset was within the first 10 years of life in 90% of patients, with focal seizures being the most prevalent. Focal cortical dysplasia (FCD) was the most common etiology present in 50% of patients. These children had normal neuroimaging studies and intractable epilepsy. However, seizure freedom was achieved following surgical resection of the epileptogenic zone. Conclusions: We demonstrated that patients with midline epileptic discharges are associated with intractable focal seizures and early seizure onset. Despite normal neuroimaging reports, FCD was the most common pathology. Thus our study suggests early localization and resection of the epileptogenic zone may be beneficial for achieving seizure freedom in children with this electroclinical syndrome.

Critical Appraisal of Cenobamate as Adjunctive Treatment of Focal Seizures in Adults.

Cenobamate (CNB) is the latest antiseizure medication (ASM) authorized for the treatment of focal-onset seizures in adults. Although the precise mechanism of action of CNB is not yet fully understood, this drug inhibits the persistent, rather than transient, voltage-gated sodium channel currents and is a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors, differently from benzodiazepines. CNB has a non-linear pharmacokinetic with a terminal half-life range of about 50/60 hours within the therapeutic dose range, which allows once daily administration. Cenobamate inhibits cytochrome P450 (CYP) 2C19 and induces CYP3A4 and 2B6, and hence can potentially interact with ASMs (eg, phenytoin, carbamazepine and clobazam) and no-ASMs drugs. In two randomized, double-blind, placebo-controlled trials in patients with focal epilepsies, CNB has shown a particularly good efficacy with a rate of seizure freedom of about 20% during the maintenance period in participants treated with the dose of 400 mg/day. The most common treatment-emergent adverse effects include central nervous system-related symptoms, like dizziness, diplopia, somnolence, and gait disturbances. Safety issues of particular interest are severe skin reactions (drug reaction with eosinophilia and systemic symptoms) and QT shortening, which contraindicates its use in subjects with familial short QT syndrome or in combination with other QT-shortening drugs. The recommended starting dose is 12.5 mg/day, which can be gradually titrated to the target dose (200 mg/day) and further increased up to 400 mg/day. There are several aspects of CNB that need to be still addressed, including the long-term efficacy and the efficacy in patients with generalized seizures. Ongoing studies will clarify these issues. The clinical relevance of the peculiar pharmacokinetics and the pattern of drug–drug interactions also require further investigation.

Evaluation of medication adherence and medication beliefs among patients with epilepsy

AimThis study explored medication adherence and medication beliefs of patients with epilepsy and evaluated the relationship between these two factors. MethodsThis descriptive, cross-sectional, correlational study was conducted with 174 patients with epilepsy who were referred to the neurology outpatient clinic of a university hospital in Erzurum, Turkey, between February 10, 2020 and December 30, 2020. The data were collected using the Descriptive Information Form, The eight-item Morisky Medication Adherence Scale (MMAS-8), and the Beliefs about Medicines Questionnaire (BMQ-T). ResultsThe mean age of the patients was 33.06 ± 11.94 years, and the mean duration of time since diagnosis was 12.91 ± 10.73 years. In terms of demographic information, 60.3% of the patients were single, 58% had low income or were unemployed, 53.4% had five or more seizures within the last year, 40.8% had focal onset seizures, 69% had no other chronic disease, and 76.4% used more than one medicine. The patients’ mean MMAS-8 score was 3.25 ± 2.13. The mean scores for the specific concern subscale was 3.65 ± 0.85, 1.81 ± 0.75 for the specific necessity subscale, 4.19 ± 0.76 for the general overuse subscale, and 3.14 ± 1.41 for the general harm subscale. The regression analysis revealed that general overuse and general harm negatively affected the MMAS-8 total score. ConclusionPatients with epilepsy reported low medication adherence and were found to have concerns about the harms and side effects of the medicines they were using; they had negative perceptions of the purpose of medicines; they had high beliefs about the harms of medicines; and they had low beliefs about their personal treatment needs. The patients were generally found to have negative beliefs about medicines, which negatively affected their medication adherence.

Pharmacokinetics and safety of cenobamate, a novel antiseizure medication, in healthy Japanese, and an ethnic comparison with healthy non-Japanese.

Cenobamate (XCOPRI and ONTOZRY) is a novel antiseizure medication for the treatment of focal‐onset seizures. Nonetheless, there is limited information on the pharmacokinetics (PKs), safety, and efficacy of cenobamate in Asian people, including Japanese people. This study aimed to evaluate the PKs and safety of cenobamate after a single oral dose in healthy Japanese subjects and to compare the PKs with that reported in non‐Japanese subjects. A randomized, double‐blind, placebo‐controlled, single ascending dose study was conducted at four dose levels of 50, 100, 200, and 400 mg. Subjects were randomly assigned to cenobamate or placebo in a 6:2 ratio. Cenobamate was rapidly absorbed, reaching its maximum plasma concentration (Cmax) in 0.75 to 2.25 h, and was eliminated with a mean half‐life of 37.0 to 57.7 h. The Cmax increased dose proportionally, whereas area under the concentration‐time curve increased more than dose proportionally, which was consistent with the findings in non‐Japanese subjects. The systemic exposure of cenobamate was comparable between Japanese and non‐Japanese subjects at all dose levels evaluated. All adverse events were mild in severity, and their incidence did not show dose‐dependent trends. Furthermore, there were no clinically significant issues in safety parameters, including sedation tests, neurologic examinations, and Columbia Suicide Severity Rating Scale interviews. In conclusion, the systemic exposure of cenobamate after a single dose in Japanese subjects increased by dose, which was similar to the pattern in non‐Japanese subjects. In addition, a single dose of cenobamate was well‐tolerated in the dose range of 50 to 400 mg in healthy Japanese subjects.

Wearable Reduced-Channel EEG System for Remote Seizure Monitoring.

Epitel has developed Epilog, a miniature, wireless, wearable electroencephalography (EEG) sensor. Four Epilog sensors are combined as part of Epitel's Remote EEG Monitoring platform (REMI) to create 10 channels of EEG for remote patient monitoring. REMI is designed to provide comprehensive spatial EEG recordings that can be administered by non-specialized medical personnel in any medical center. The purpose of this study was to determine how accurate epileptologists are at remotely reviewing Epilog sensor EEG in the 10-channel “REMI montage,” with and without seizure detection support software. Three board certified epileptologists reviewed the REMI montage from 20 subjects who wore four Epilog sensors for up to 5 days alongside traditional video-EEG in the EMU, 10 of whom experienced a total of 24 focal-onset electrographic seizures and 10 of whom experienced no seizures or epileptiform activity. Epileptologists randomly reviewed the same datasets with and without clinical decision support annotations from an automated seizure detection algorithm tuned to be highly sensitive. Blinded consensus review of unannotated Epilog EEG in the REMI montage detected people who were experiencing electrographic seizure activity with 90% sensitivity and 90% specificity. Consensus detection of individual focal onset seizures resulted in a mean sensitivity of 61%, precision of 80%, and false detection rate (FDR) of 0.002 false positives per hour (FP/h) of data. With algorithm seizure detection annotations, the consensus review mean sensitivity improved to 68% with a slight increase in FDR (0.005 FP/h). As seizure detection software, the automated algorithm detected people who were experiencing electrographic seizure activity with 100% sensitivity and 70% specificity, and detected individual focal onset seizures with a mean sensitivity of 90% and mean false alarm rate of 0.087 FP/h. This is the first study showing epileptologists' ability to blindly review EEG from four Epilog sensors in the REMI montage, and the results demonstrate the clinical potential to accurately identify patients experiencing electrographic seizures. Additionally, the automated algorithm shows promise as clinical decision support software to detect discrete electrographic seizures in individual records as accurately as FDA-cleared predicates.

Nocardia abscessus brain abscess in an immunocompetent patient with bronchiectasis

A 56 year-old woman presented with new onset focal seizure with a history of bronchiectasis. Brain abscess was diagnosed by magnetic resonance. She was confirmed to be immunocompetent and had histoplasmosis, tuberculosis, and infective endocarditis ruled out. Nocardia sp. was isolated from the brain abscess and identified as Nocardia abscessus complex by 16S rRNA sequencing. She was discharged on trimethoprim/sulfamethoxazole. Nocardia sp. is a cause of brain abscesses in patients with underlying pulmonary structural disease like bronchiectasis. Nocardia identification is of paramount importance as it is not treated with empiric antimicrobial therapy.

Nocardia abscessus brain abscess in an immunocompetent patient with bronchiectasis

A 56 year-old woman presented with new onset focal seizure with a history of bronchiectasis. Brain abscess was diagnosed by magnetic resonance. She was confirmed to be immunocompetent and had histoplasmosis, tuberculosis, and infective endocarditis ruled out. Nocardia sp. was isolated from the brain abscess and identified as Nocardia abscessus complex by 16S rRNA sequencing. She was discharged on trimethoprim/sulfamethoxazole. Nocardia sp. is a cause of brain abscesses in patients with underlying pulmonary structural disease like bronchiectasis. Nocardia identification is of paramount importance as it is not treated with empiric antimicrobial therapy.

Safety and tolerability of adjunctive eslicarbazepine acetate in adolescents with focal-onset seizures: Data from three double-blind, placebo-controlled randomized clinical studies

Adolescence is a critical developmental period in which major metabolic changes occur.1 We aimed at evaluating safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in adolescents (ages 12–18) with refractory focal-onset seizures.