The role of stand-alone videos in the diagnosis of seizures.

The diagnosis of seizures and seizure mimics relies primarily on the history, but history has well-known limitations. Video recordings of events are a powerful extension of the history because they allow neurologists to view the events in question. In addition, they are readily available in situation, whereas the gold standard of EEG-video is not. That includes underserved or rural areas, and events that are too infrequent to be captured during a few days of EEG-video monitoring. Brief cellphone videos have been shown to be valuable to suggest or guide the correct diagnosis.

Online seizure first aid certification program is an effective means of improving student knowledge and self efficacy surrounding epilepsy.

INTRODUCTION: Epilepsy is a neurological disorder, characterized by recurring seizures, affecting more than 3.4 million adults and children throughout the United States. Still, there are sizable gaps in awareness and knowledge of this disorder, and persistent misunderstandings and stigmas surrounding epilepsy and seizure first aid (SFA) pose a risk to those living with this condition. The Epilepsy Foundation, with support from the Centers for Disease Control and Prevention (CDC), has developed programs to address the issue of insufficient public education and awareness surrounding epilepsy. One of these programs is a free, accessible online Seizure Recognition and First Aid Certification program, established in 2021. We aimed to evaluate the effectiveness of the Epilepsy Foundation's online Seizure Recognition and First Aid Certification program in improving student knowledge of epilepsy and appropriate bystander-intervention methods to assist a person experiencing a seizure. METHODS: The Epilepsy Foundation's online Seizure Recognition and First Aid Certification course evaluates student performance via a 16-question knowledge assessment and six question self-efficacy assessment provided both before and after completion of the course. Pre- and post-course scores of students who enrolled between December of 2021 and September of 2022 were collected. Average score improvement was evaluated via the difference in pre-course and post-course first-attempt scores. Statistical significance was evaluated using paired sample, two-tailed t-tests of pre-course and post-course scores. RESULTS: Average pre-course knowledge score was 74.33% (n = 10,371, σ2 = 3.04%), post-course score was 88.04% (n = 10,371, σ2 = 0.83%), and score difference was 13.71% (p < 0.001). Average pre-course self-efficacy score was 63.44% (n = 8,046, σ2 = 4.71%), post-course score was 87.08% (n = 8,046, σ2 = 1.68%), and score difference was 23.64% (p < 0.001). CONCLUSION: We found a significant increase in knowledge and self-efficacy assessment scores after students completed the online Seizure Recognition and First Aid Certification course, suggesting that the program is an effective method of improving the understanding of epilepsy and bystander interventions to assist a person who is experiencing a seizure. In the future, awareness should continue to be promoted through SFA training programs and improving accessibility to such programs so that the risks associated with experiencing a seizure without receiving assistance are reduced for people living with epilepsy.

Efficacy of highly purified cannabidiol (CBD) in typical absence seizures: A pilot study.

OBJECTIVES: Clinical trials for typical absence seizures are notoriously difficult, because those seizures are clinically subtle and brief, so that seizure counts by caregivers are inaccurate. As a result, treatment options are limited. Currently, there are no published studies on the use of CBD in typical absence seizures. This pilot study aims to evaluate the efficacy of pharmaceutical grade CBD in typical absence seizures. METHODS: We prospectively enrolled 14 patients aged 6 years and older, diagnosed with typical absence seizures. A baseline 24-hour ambulatory EEG was conducted, followed by a second 24-hour EEG after 90 days of treatment. The outcome was an objective measure of spike-wave complexes (SWC) burden change from pre- to post- treatment. RESULTS: After taking CBD for 90 days, 9 (64.3%) patients had an increase in SWC (ranging from 8% to 2876.5%) and 5 (35.7%) had a decrease in SWC (ranging from 62.3% to 98.9%). Of the 5 patients who had a decrease, 3 (60%) were on concomitant ethosuximide (with or without other ASMs). All 3 patients on CBD and ethosuximide improved. CONCLUSIONS: Although based on a small subset of patients, our results suggest that CBD may not be effective for typical absence seizures. However, patients on concomitant ethosuximide or on CBD monotherapy were more likely to improve.

ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsy.

Vagus Nerve Stimulation (VNS) therapy is widely understood to provide clinically meaningful improvements in seizure control to patients with drug-resistant epilepsy, and has been a staple in the clinical armamentaria available to epileptologists for over 25 years. Despite the long history of evidence-based reviews by neurology professional societies, there is still evidence of a practice gap in VNS titration and dosing that aims to maximize clinical benefit. Recent retrospective analyses have strongly argued for a more consistent application of a population-wide target dose of VNS, and further argued the importance of quickly achieving this target dose to hasten the onset of clinical benefits; however, these analyses failed to provide evidence for practical implementation. Herein, we describe a randomized controlled trial assessing the impact of titrating VNS according to three different protocols to achieve the target dose of 1.5 mA at 500µsec, for a 20-Hz signal frequency. The study was registered as NCT02385526 on March 11, 2015. Sixty-two patients were randomized into treatment groups that followed different titration protocols. One protocol (Group A) was designed to align with currently accepted professional guidance for VNS titration and the manufacturer's labeling for VNS in epilepsy (Heck et al., 2002), while the other two protocols were derived from VNS applications in other therapeutic areas. Group A participants were most likely to achieve the target dose parameters in 12 weeks or less (81.8%), with a median time-until-achievement of the target dose of 8.1 weeks, while less than 60% of patients in other groups were able to achieve the same endpoint. Participants in all groups experienced low levels of transient tolerability concerns and adverse events, suggesting titration to the target dose in 12 weeks or less following the Group A protocol is generally acceptable to most patients. These findings indicate that patients receiving VNS for epilepsy can achieve the manufacturer-recommended dose range in 12 weeks or less. A wider implementation of the approach will likely improve the clinical impact of VNS on seizure control and prevent undertreatment.

Use of new intranasal benzodiazepines at a typical adult epilepsy center.

OBJECTIVE: The aim of this study was to review out-of-hospital use of intranasal diazepam and midazolam for treatment of acute repetitive seizures (ARS) at a typical adult epilepsy center. METHODS: Data were collected through chart review and by telephone calls to either the patient or the caregiver regarding drug effectiveness, overall satisfaction, and adverse events. RESULTS: We identified 96 patients who were prescribed either benzodiazepine. Thirty-nine patients in the diazepam group and 38 patients in the midazolam group were able to be contacted and were included in the study. Sixty-two percent of patients in the diazepam group and 55% of patients in the midazolam group had used the medication at the time of data collection. Of these patients, 83% of patients in the diazepam group and 85% of patients in the midazolam group reported cessation of seizures after either the first or second dose. In comparison of the average patient satisfaction between intranasal diazepam and midazolam, there was no statistical significance (4.25 ± 1.22 vs 3.95 ± 1.35; p = 0.42). Adverse events were minor, included fatigue, nasal discomfort, headache, and dizziness. DISCUSSION: The use of the two new intranasal benzodiazepines was roughly divided equally. Slightly more than half of the patients who were prescribed the medication had used it. The overall satisfaction of the two medications was comparable. These findings highlight the principal usability of intranasal diazepam and midazolam in adults with ARS.

Value of smartphone videos for diagnosis of seizures: Everyone owns half an epilepsy monitoring unit.

The diagnosis of epilepsy is primarily based on the history and the verbal description of the events in question. Smartphone videos are increasingly used to assist in the diagnosis. The purpose of this study is to evaluate their value for the diagnosis of seizures. We prospectively collected smartphone videos from patients who presented to our epilepsy center over two years. The video-based diagnosis was then compared to the eventual diagnosis based on video-electroencephalographic (EEG) monitoring with recorded episodes. Video-EEG studies and smartphone videos were reviewed by two separate physicians, each blinded to the other's interpretation. Fifty-four patients were included in the final analysis (mean age = 34.7 years, SD = 17 years). Data (either smartphone video or video-EEG monitoring) were inconclusive in 18 patients. Of the 36 patients with conclusive data, 34 (94%) were in agreement. Smartphone video interpretation can be a useful adjunctive tool in the diagnosis of seizure-like events.

Video quality using outpatient smartphone videos in epilepsy: Results from the OSmartViE study.

BACKGROUND AND PURPOSE: The aim of this study was to evaluate the quality of smartphone videos (SVs) of neurologic events in adult epilepsy outpatients. The use of home video recording in patients with neurological disease states is increasing. Experts interpretation of outpatient smartphone videos of seizures and neurological events has demonstrated similar diagnostic accuracy to inpatient video-electroencephalography (EEG) monitoring. METHODS: A prospective, multicenter cohort study was conducted to evaluate SV quality in patients with paroxysmal neurologic events from August 15, 2015 through August 31, 2018. Epileptic seizures (ESs), psychogenic nonepileptic attacks (PNEAs), and physiologic nonepileptic events (PhysNEEs) were confirmed by video-EEG monitoring. Experts and senior neurology residents blindly viewed cloud-based SVs without clinical information. Quality ratings with regard to technical and operator-driven metrics were provided in responses to a survey. RESULTS: Forty-four patients (31 women, age 45.1 years [r = 20-82]) were included and 530 SVs were viewed by a mean of seven experts and six residents; one video per patient was reviewed for a mean of 133.8 s (r = 9-543). In all, 30 patients had PNEAs, 11 had ESs, and three had PhysNEEs. Quality was suitable in 70.8% of SVs (375/530 total views), with 36/44 (81.8%) patient SVs rated as adequate by the majority of reviewers. Accuracy improved with the presence of convulsive features from 72.4% to 98.2% in ESs and from 71.1% to 95.7% in PNEAs. An accurate diagnosis was given by all reviewers (100%) in 11/44 SVs (all PNEAs). Audio was rated as good by 86.2% of reviewers for these SVs compared with 75.4% for the remaining SVs (p = 0.01). Lighting was better in SVs associated with high accuracy (p = 0.06), but clarity was not (p = 0.59). Poor video quality yielded unknown diagnoses in 24.2% of the SVs reviewed. Features hindering diagnosis were limited interactivity, restricted field of view and short video duration. CONCLUSIONS: Smartphone video quality is adequate for clinical interpretation in the majority of patients with paroxysmal neurologic events. Quality can be optimized by encouraging interactivity with the patient, adequate duration of the SV, and enlarged field of view during videography. Quality limitations were primarily operational though accuracy remained for SV review of ESs and PNEAs.

Fish soup for the falling sickness: Tracing epilepsy through Hmong and Western beliefs.

Hmong communities originated in China but today are located across the globe. Salvation, health, and well-being in Hmong tradition are contingent upon pleasing spirits and ancestors. While most diseases are believed to reflect the displeasure of spirits and ancestors, epilepsy is unique in that it portends a heightened capacity for achieving an elevated level of spirituality, which has led it to be deemed honorable by Hmong society members. This stands in stark contrast to some contexts within which epilepsy has been historically understood in the West in which the disease was believed to originate from sin and evil. If and how societal response toward persons with epilepsy (PWE) in Hmong communities differ from that in other Western communities in a way that parallels these differences in beliefs regarding the etiology and significance of the seizures is unknown. Understanding this may have implications that guide efforts in combatting stigma affecting PWE.

Outcome of prolonged video-EEG monitoring in a new VA monitoring unit.

BACKGROUND AND OBJECTIVE: For patients with refractory seizures or seizure-like activity, prolonged inpatient video-electroencephalography (EEG) (v-EEG) is standard of care to guide diagnosis and management. The purpose of this study was to describe the outcome of v-EEG in a new Veterans' Administration (VA) hospital epilepsy monitoring unit (EMU). METHODS: We reviewed all prolonged (>24 h) inpatient v-EEGs performed in our EMU (2 beds) at the James A Haley VA in Tampa, FL over a five-and-a-half-year period (11/2013-07/2019). A total of 216 prolonged v-EEGs were performed. The patient population consisted of adult veterans (185 males, 31 females) ranging from 21 years to 89 years old (mean 52.5). The duration of monitoring ranged from 24 h to 9 days (mean 3.6 days). RESULTS: Of the 216 studies, 39 (18%) exclusively had epileptic seizures (ES). Of these, 37 (95%) had focal seizures, and 2 (5%) had generalized seizures. Of the 37 cases with focal seizures, all but 2 had clear ictal changes on EEG. Eighteen (8.5%) EEG studies revealed interictal epileptiform abnormalities without a clinical event. Sixty-eight (31.5%) of the v-EEGs had exclusively nonepileptic events (NEE). Of these, 27 (12.5%) were psychogenic nonepileptic seizures (PNES), and 41 (19%) were other NEE. Ninety-one (42%) of the studies were inconclusive, either because of lack of events captured (63) or because the events recorded were not the patient's typical episodes (27). SIGNIFICANCE: Compared to non-VA series, we found a lower proportion of PNES, and a higher proportion of inconclusive studies.

Ceasing Antiquated Conceptions: A Telling of the Early and Evolving History of Epilepsy.

The word epilepsy is derived from the Greek word epilambanein, meaning "to seize." This term came to embody the disease as early descriptions characterized seizures as events in which the faculties of the mind and body were "seized" from the individual. This notion of seizing the mind and body's faculties has in essence remained a constant throughout the evolution of epilepsy. The theories elucidating the significance of the event, however, have surely shifted with the times, reflecting an elegant battle among magic, science, and theology. Subsequent advents in clinical observation, diagnostic evaluation, and therapeutics unfurled many mysteries of the brain and revolutionized prevailing theories, landing epilepsy as it is known today far beyond the primitive and highly supernatural notions that predominated in antiquity.

Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial.

BACKGROUND: Patients with Lennox-Gastaut syndrome, a rare, severe form of epileptic encephalopathy, are frequently treatment resistant to available medications. No controlled studies have investigated the use of cannabidiol for patients with seizures associated with Lennox-Gastaut syndrome. We therefore assessed the efficacy and safety of cannabidiol as an add-on anticonvulsant therapy in this population of patients. METHODS: In this randomised, double-blind, placebo-controlled trial done at 24 clinical sites in the USA, the Netherlands, and Poland, we investigated the efficacy of cannabidiol as add-on therapy for drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome. Eligible patients (aged 2-55 years) had Lennox-Gastaut syndrome, including a history of slow (<3 Hz) spike-and-wave patterns on electroencephalogram, evidence of more than one type of generalised seizure for at least 6 months, at least two drop seizures per week during the 4-week baseline period, and had not responded to treatment with at least two antiepileptic drugs. Patients were randomly assigned (1:1) using an interactive voice response system, stratified by age group, to receive 20 mg/kg oral cannabidiol daily or matched placebo for 14 weeks. All patients, caregivers, investigators, and individuals assessing data were masked to group assignment. The primary endpoint was percentage change from baseline in monthly frequency of drop seizures during the treatment period, analysed in all patients who received at least one dose of study drug and had post-baseline efficacy data. All randomly assigned patients were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT02224690. FINDINGS: Between April 28, 2015, and Oct 15, 2015, we randomly assigned 171 patients to receive cannabidiol (n=86) or placebo (n=85). 14 patients in the cannabidiol group and one in the placebo group discontinued study treatment; all randomly assigned patients received at least one dose of study treatment and had post-baseline efficacy data. The median percentage reduction in monthly drop seizure frequency from baseline was 43·9% (IQR -69·6 to -1·9) in the cannibidiol group and 21·8% (IQR -45·7 to 1·7) in the placebo group. The estimated median difference between the treatment groups was -17·21 (95% CI -30·32 to -4·09; p=0·0135) during the 14-week treatment period. Adverse events occurred in 74 (86%) of 86 patients in the cannabidiol group and 59 (69%) of 85 patients in the placebo group; most were mild or moderate. The most common adverse events were diarrhoea, somnolence, pyrexia, decreased appetite, and vomiting. 12 (14%) patients in the cannabidiol group and one (1%) patient in the placebo group withdrew from the study because of adverse events. One patient (1%) died in the cannabidiol group, but this was considered unrelated to treatment. INTERPRETATION: Add-on cannabidiol is efficacious for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome and is generally well tolerated. The long-term efficacy and safety of cannabidiol is currently being assessed in the open-label extension of this trial. FUNDING: GW Pharmaceuticals.

Critique of the 2017 epileptic seizure and epilepsy classifications.

This article critiques the International League Against Epilepsy (ILAE) 2015-2017 classifications of epilepsy, epileptic seizures, and status epilepticus. It points out the following shortcomings of the ILAE classifications: (1) they mix semiological terms with epileptogenic zone terminology; (2) simple and widely accepted terminology has been replaced by complex terminology containing less information; (3) seizure evolution cannot be described in any detail; (4) in the four-level epilepsy classification, level two (epilepsy category) overlaps almost 100% with diagnostic level one (seizure type); and (5) the design of different classifications with distinct frameworks for newborns, adults, and patients in status epilepticus is confusing. The authors stress the importance of validating the new ILAE classifications and feel that the decision of Epilepsia to accept only manuscripts that use the ILAE classifications is premature and regrettable.

Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis.

OBJECTIVE: The objective was to assess the efficacy and safety of adjunctive brivaracetam (BRV) with concomitant use of lamotrigine (LTG) or topiramate (TPM) in patients with uncontrolled focal seizures. METHODS: Data were pooled from three randomized, placebo-controlled Phase III studies (NCT00490035/N01252, NCT00464269/N01253, NCT01261325/N01358) of adults with focal (partial-onset) seizures. Patients taking concomitant levetiracetam were excluded from the efficacy populations, but included in the safety populations. This post-hoc analysis reports data from patients taking BRV in the approved therapeutic range (50-200mg/day) concomitantly with LTG or TPM. RESULTS: The number of patients in each of the three BRV dosage groups was small, particularly for the TPM subgroup. Mean percent reduction over placebo in baseline-adjusted focal seizure frequency/28days for BRV 50, 100, and 200mg/day was 8.7, 5.3, and 8.9 in the LTG subgroup (n=220), and 8.4, 21.3, and -4.2 in the TPM subgroup (n=122). The ≥50% responder rate with concomitant LTG or TPM with BRV 50, 100, and 200mg/day or placebo was LTG: 28.1%, 36.1%, 34.1%, and 29.1%; and TPM: 14.3%, 44.4%, 25.0%, and 17.5%. There were numerically ≥50%, ≥75%, ≥90%, and 100% responder rates for patients taking BRV ≥50mg/day compared with placebo in both subgroups. In the LTG and TPM safety populations (n=245 versus n=125), treatment-emergent adverse events (TEAEs) were reported with LTG 68.7% versus 68.4%, and TPM 65.6% versus 57.8% (BRV ≥50mg/day versus placebo). Discontinuations due to TEAEs versus placebo were LTG 7.3% versus 6.3% and TPM 8.2% versus 4.7%. The three most frequently reported TEAEs for both subgroups were somnolence, dizziness, and fatigue. Of these, the incidence of fatigue in the LTG population appeared to increase with dose. SIGNIFICANCE: In this post-hoc pooled analysis, BRV administered with concomitant LTG or TPM reduced seizure frequency and was generally well tolerated for BRV doses of 50-200mg/day.

Putting it all together: Options for intractable epilepsy: An updated algorithm on the use of epilepsy surgery and neurostimulation.

For drug-resistant epilepsy, nonpharmacologic treatments should be considered early rather than late. Of the nondrug treatments, only resective surgery can be curative. Neurostimulation is palliative, i.e., not expected to achieve a seizure-free outcome. While resective surgery is the goal, other options are necessary because the majority of patients with drug-resistant epilepsy are not surgical candidates, and others have seizures that fail to improve with surgery or have only partial improvement but not seizure freedom. Neurostimulation modalities include vagus nerve stimulation (VNS), responsive neurostimulation (RNS), and deep brain stimulation (DBS), each with its own advantages, disadvantages, and side effects. In most scenarios, determined by noninvasive evaluation, especially EEG and MRI, several strategies are reasonable. For focal epilepsies, the choices are between resective surgery, with or without intracranial EEG, and all three modalities of neurostimulation. In situations where resective surgery is likely to result in seizure freedom, such as mesiotemporal lobe epilepsy or lesional focal epilepsy, resection (standard, laser, or radiofrequency) is preferred. For difficult cases like extratemporal nonlesional epilepsies, neurostimulation offers a less invasive option than resective surgery. For generalized and multifocal epilepsies, VNS is an option, RNS is not, and DBS has only limited evidence. "This article is part of the Supplement issue Neurostimulation for Epilepsy."

Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures.

OBJECTIVE: To evaluate the nature and incidence of psychiatric and cognitive adverse events (AEs) reported with eslicarbazepine acetate (ESL) used as adjunctive treatment for refractory partial-onset seizures (POS) in adults. METHODS: This was a post-hoc analysis of data pooled from three randomized double-blind, placebo-controlled trials (BIA-2093-301, -302, -304). After an 8-week baseline period, patients received placebo or adjunctive ESL 400mg (studies 301 and 302 only), 800mg, or 1200mg once daily (QD) for 14weeks (2-week titration period, 12-week maintenance period). Psychiatric and cognitive AEs were identified from individual patient data. Suicidality was also evaluated using the Columbia-Classification Algorithm of Suicide Assessment (C-CASA), or the Columbia-Suicide Severity Rating Scale (C-SSRS). P-values were obtained using the chi-square test of independence or Fisher's exact test, without correcting for multiplicity. RESULTS: The analysis population included 1447 patients (ESL, n=1021; placebo, n = 426). Psychiatric treatment-emergent AEs (TEAEs) occurred in 10.8% of patients receiving ESL, and in a comparable proportion (10.3%) of patients receiving placebo (p=0.802). The incidence of depression and suicidality-related TEAEs was higher for ESL (7.4%) vs. placebo (3.8%) (p=0.009). The occurrence of these TEAEs differed between treatment groups (p = 0.010), but there was no notable trend between increasing ESL dose and increasing incidence of depression and suicidality-related TEAEs. Aggression/hostility-related TEAEs occurred in <0.1% of patients taking ESL vs. 0.9% taking placebo. The incidence of cognitive TEAEs was higher for ESL (7.1%) vs. placebo (4.0%) (p=0.023); incidences of memory impairment, attention disturbance, apathy, and aphasia were higher for ESL 1200mg than for other treatment groups. Incidences of psychiatric and cognitive serious AEs (SAEs) were 0.6% and 0.2% with ESL, and 0.5% and 0% with placebo, respectively. Psychiatric and cognitive TEAEs leading to discontinuation occurred in 1.9% and 1.4% of patients taking ESL, and 0.7% and 0.5% taking placebo, respectively. CONCLUSIONS: In phase III clinical trials of adjunctive ESL for treatment-refractory POS, psychiatric and cognitive TEAEs were reported infrequently with ESL and placebo. The incidences of depression and suicidality-related TEAEs and of cognitive TEAEs were higher for patients taking ESL vs. placebo. Incidences of psychiatric and cognitive SAEs, and TEAEs leading to discontinuation, were low with ESL and placebo.

An analysis of quality of life (QOL) in patients with epilepsy and comorbid psychogenic nonepileptic seizures (PNES) after vagus nerve stimulation (VNS).

PURPOSE: Patients with epilepsy (PWE) may suffer from comorbid psychogenic nonepileptic seizures (PNES). The efficacy of vagus nerve stimulation (VNS) in the treatment of epilepsy and depression is established, however the impact on PNES is unknown. Since many patients with PNES have comorbid depression, we explored the impact on quality of life (QOL) that VNS has on PWE and PNES. METHODS: The video electroencephalogram (vEEG) of all patients who underwent VNS at our institution was reviewed. Patients diagnosed with both psychogenic seizures and epileptic seizures on their vEEG were included in this study. These patients were contacted, and given a QOLIE-31 survey to assess their quality of life after VNS. Patients also completed a separate survey created by our group to categorize the quartile of their improvement. Pre-operative psychiatric disease was retrospectively reviewed. RESULTS: From a period of 2001 to 2016, 518 patients underwent placement of VNS for drug resistant epilepsy (DRE) at our institution. In total, 16 patients were diagnosed with both epilepsy and PNES. 11/16 patients responded to our questionnaire and survey. 9 out of 11 patients felt that their epileptic seizures had improved after VNS, while 7 of the 11 patients felt that their psychogenic episodes had improved. 2(28.6%), 1 (14.3%), and 4 (57.1%) of participants said their PNES improved by 25-50%, 50-75%, and 75-100%, respectively. 3(27.3%), 3 (27.3%), 1 (9.1%), and 4 (36.4%) of the participants said their epileptic seizures improved by 0-25%, 25-50%, 50-75%, and 75-100%, respectively. The average overall score for quality of life for the study participants was found to be 51 (±8) out of 100. CONCLUSION: Patients with epilepsy and comorbid PNES may benefit from VNS. It is unclear whether the benefit is conferred strictly from decreased epileptic seizure burden. The possible effect on PNES may be related to the known effect of VNS on depression. Further studies are necessary to elucidate the role of VNS in the treatment of PNES and possibly other psychiatric disease.

Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance--The U.S. E-37 Trial.

OBJECTIVES: The Automatic Stimulation Mode (AutoStim) feature of the Model 106 Vagus Nerve Stimulation (VNS) Therapy System stimulates the left vagus nerve on detecting tachycardia. This study evaluates performance, safety of the AutoStim feature during a 3-5-day Epilepsy Monitoring Unit (EMU) stay and long- term clinical outcomes of the device stimulating in all modes. MATERIALS AND METHODS: The E-37 protocol (NCT01846741) was a prospective, unblinded, U.S. multisite study of the AspireSR(®) in subjects with drug-resistant partial onset seizures and history of ictal tachycardia. VNS Normal and Magnet Modes stimulation were present at all times except during the EMU stay. Outpatient visits at 3, 6, and 12 months tracked seizure frequency, severity, quality of life, and adverse events. RESULTS: Twenty implanted subjects (ages 21-69) experienced 89 seizures in the EMU. 28/38 (73.7%) of complex partial and secondarily generalized seizures exhibited ≥20% increase in heart rate change. 31/89 (34.8%) of seizures were treated by Automatic Stimulation on detection; 19/31 (61.3%) seizures ended during the stimulation with a median time from stimulation onset to seizure end of 35 sec. Mean duty cycle at six-months increased from 11% to 16%. At 12 months, quality of life and seizure severity scores improved, and responder rate was 50%. Common adverse events were dysphonia (n = 7), convulsion (n = 6), and oropharyngeal pain (n = 3). CONCLUSIONS: The Model 106 performed as intended in the study population, was well tolerated and associated with clinical improvement from baseline. The study design did not allow determination of which factors were responsible for improvements.