Publications by authors named "Ryan Hays"

23 Publications

  • Page 1 of 1

Non-lesional mesial temporal lobe epilepsy requires bilateral invasive evaluation.

Epilepsy Behav Rep 2021 27;15:100441. Epub 2021 Mar 27.

Department of Neurology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-8508, USA.

Purpose: Mesial temporal lobe epilepsy (MTLE) usually responds well to surgical treatment, although in non-lesional cases up to 50% of patients experience seizure relapse. The possibility of bilateral independent seizure onset should be considered as a reason for epilepsy surgery failure.

Methods: In a cohort of 177 patients who underwent invasive presurgical evaluation with stereo-tactically placed electrodes in two level four epilepsy centers, 29 had non-lesional MTLE. Invasive evaluation results are described.

Results: Among 29 patients with non-lesional MRI and mesial temporal lobe seizure onset recorded during stereo-EEG (SEEG) evaluation, four patients with unilateral preimplantation hypothesis had independent bilateral mesial temporal seizures on SEEG despite of unilateral non-invasive evaluation data. Three of these patients were treated with bitemporal responsive neurostimulator system (RNS). Independent bilateral mesial temporal seizures have been confirmed on RNS ECoG (electrocorticography). The fourth patient underwent right anterior temporal lobectomy.

Conclusion: We propose that patients with non-lesional mesial temporal lobe epilepsy would benefit from bilateral invasive evaluation of mesial temporal structures to predict those patients who would be at most risk for surgical failure. Neurostimulaiton could be an initial treatment option for patients with independent bitemporal seizure onset.
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http://dx.doi.org/10.1016/j.ebr.2021.100441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8058515PMC
March 2021

Physical activity status and quality of life in patients with epilepsy - Survey from level four epilepsy monitoring units.

Epilepsy Res 2021 Jul 9;173:106639. Epub 2021 Apr 9.

Department of Neurology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, TX, 75390, USA. Electronic address:

Purpose: People with epilepsy (PWE) tend to have sedentary lifestyles which may predispose them to a lower perceived quality of life (QOL). Moreover, the relationship between physical activity (PA) and QOL in populations of PWE with high disease burden has been under-studied. The goal of this study was to evaluate PA level and its impact on health-related QOL in PWE who were admitted to Level-4 epilepsy monitoring units (EMU).

Methods: In this prospective observational study, 200 patients from two EMUs in Dallas, Texas completed the following standard surveys: Rapid Assessment of Physical Activity (RAPA), the Quality of Life in Epilepsy (QOLIE-31), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. Information on self-reported epilepsy history, severity of disease, and socioeconomic status were also collected. The diagnosis of epilepsy was confirmed by video-EEG monitoring.

Results: Among the 200 who completed the survey, 113 had a diagnosis of epilepsy and 109 of them completed the RAPA. Ninety-two (84 %) of these PWE reported a sedentary level of physical activity (RAPA < 6) and 16 % reported an active level (RAPA ≥ 6). Self-reported QOL was slightly higher in PWE with an active level of PA compared to PWE with a sedentary level of PA (63.8 ± 15.0 vs 53.7 ± 17.9, p = 0.07), even though there was no difference in the severity of self-reported mood symptoms. After controlling for employment and seizure frequency, physical activity level measured by RAPA score was also positively related to QOL (r = 0.39, p = 0.01) and negatively correlated with anxiety symptoms (r = -0.28, p = 0.02) and depression symptoms (r = -0.25, p = 0.04).

Conclusion: The majority of PWE in this survey reported sedentary lifestyles despite most of them being young to middle-aged adults. Higher PA level was associated with fewer self-reported mood symptoms and higher QOL. In conjunction with the literature, these results suggest that PWE with a wide range of disease burden should be encouraged to participate in regular exercise to potentially improve QOL.
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http://dx.doi.org/10.1016/j.eplepsyres.2021.106639DOI Listing
July 2021

Digital phenotyping of student mental health during COVID-19: an observational study of 100 college students.

J Am Coll Health 2021 Mar 26:1-13. Epub 2021 Mar 26.

Division of Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

This study assessed the feasibility of capturing smartphone based digital phenotyping data in college students during the COVID-19 pandemic with the goal of understanding how digital biomarkers of behavior correlate with mental health. Participants were 100 students enrolled in 4-year universities. Each participant attended a virtual visit to complete a series of gold-standard mental health assessments, and then used a mobile app for 28 days to complete mood assessments and allow for passive collection of GPS, accelerometer, phone call, and screen time data. Students completed another virtual visit at the end of the study to collect a second round of mental health assessments. In-app daily mood assessments were strongly correlated with their corresponding gold standard clinical assessment. Sleep variance among students was correlated to depression scores (ρ = .28) and stress scores (ρ = .27). Digital Phenotyping among college students is feasible on both an individual and a sample level. Studies with larger sample sizes are necessary to understand population trends, but there are practical applications of the data today.
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http://dx.doi.org/10.1080/07448481.2021.1905650DOI Listing
March 2021

The high-value pharmacy enterprise framework: Advancing pharmacy practice in health systems through a consensus-based, strategic approach.

Am J Health Syst Pharm 2021 03;78(6):498-510

University of Kentucky, Lexington, KY, and UK HealthCare, Lexington, KY.

Purpose: The high-value pharmacy enterprise (HVPE) framework and constituent best practice consensus statements are presented, and the methods used to develop the framework's 8 domains are described.

Summary: A panel of pharmacy leaders used an evidence- and expert opinion-based approach to define core and aspirational elements of practice that should be established within contemporary health-system pharmacy enterprises by calendar year 2025. Eight domains of an HVPE were identified: Patient Care Services; Business Services; Ambulatory and Specialty Pharmacy Services; Inpatient Operations; Safety and Quality; Pharmacy Workforce; Information Technology, Data, and Information Management; and Leadership. Phase 1 of the project consisted of the development of draft practice statements, performance elements, and supporting evidence for each domain by panelists, followed by a phase 2 in-person meeting for review and development of consensus for statements and performance elements in each domain. During phase 3, the project cochairs and panelists finalized the domain drafts and incorporated them into a full technical report and this summary report.

Conclusion: The HVPE framework is a strategic roadmap to advance pharmacy practice by ensuring safe, effective, and patient-centered medication management and business practices throughout the health-system pharmacy enterprise. Grounded in evidence and expert recommendations, the statements and associated performance elements can be used to identify strategic priorities to improve patient outcomes and add value within health systems.
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http://dx.doi.org/10.1093/ajhp/zxaa431DOI Listing
March 2021

Deriving symptom networks from digital phenotyping data in serious mental illness.

BJPsych Open 2020 Nov 3;6(6):e135. Epub 2020 Nov 3.

Harvard Medical School, Department of Psychiatry, Beth Israel Deaconess Medical Center, USA.

Background: Symptoms of serious mental illness are multidimensional and often interact in complex ways. Generative models offer value in elucidating the underlying relationships that characterise these networks of symptoms.

Aims: In this paper we use generative models to find unique interactions of schizophrenia symptoms as experienced on a moment-by-moment basis.

Method: Self-reported mood, anxiety and psychosis symptoms, self-reported measurements of sleep quality and social function, cognitive assessment, and smartphone touch screen data from two assessments modelled after the Trail Making A and B tests were collected with a digital phenotyping app for 47 patients in active treatment for schizophrenia over a 90-day period. Patients were retrospectively divided up into various non-exclusive subgroups based on measurements of depression, anxiety, sleep duration, cognition and psychosis symptoms taken in the clinic. Associated transition probabilities for the patient cohort and for the clinical subgroups were calculated using state transitions between adjacent 3-day timesteps of pairwise survey domains.

Results: The three highest probabilities for associated transitions across all patients were anxiety-inducing mood (0.357, P < 0.001), psychosis-inducing mood (0.276, P < 0.001), and anxiety-inducing poor sleep (0.268, P < 0.001). These transition probabilities were compared against a validation set of 17 patients from a pilot study, and no significant differences were found. Unique symptom networks were found for clinical subgroups.

Conclusions: Using a generative model using digital phenotyping data, we show that certain symptoms of schizophrenia may play a role in elevating other schizophrenia symptoms in future timesteps. Symptom networks show that it is feasible to create clinically interpretable models that reflect the unique symptom interactions of psychosis-spectrum illness. These results offer a framework for researchers capturing temporal dynamics, for clinicians seeking to move towards preventative care, and for patients to better understand their lived experience.
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http://dx.doi.org/10.1192/bjo.2020.94DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745255PMC
November 2020

Digital phenotyping for mental health of college students: a clinical review.

Evid Based Ment Health 2020 Nov 30;23(4):161-166. Epub 2020 Sep 30.

Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA

Experiencing continued growth in demand for mental health services among students, colleges are seeking digital solutions to increase access to care as classes shift to remote virtual learning during the COVID-19 pandemic. Using smartphones to capture real-time symptoms and behaviours related to mental illnesses, digital phenotyping offers a practical tool to help colleges remotely monitor and assess mental health and provide more customised and responsive care. This narrative review of 25 digital phenotyping studies with college students explored how this method has been deployed, studied and has impacted mental health outcomes. We found the average duration of studies to be 42 days and the average enrolled to be 81 participants. The most common sensor-based streams collected included location, accelerometer and social information and these were used to inform behaviours such as sleep, exercise and social interactions. 52% of the studies included also collected smartphone survey in some form and these were used to assess mood, anxiety and stress among many other outcomes. The collective focus on data that construct features related to sleep, activity and social interactions indicate that this field is already appropriately attentive to the primary drivers of mental health problems among college students. While the heterogeneity of the methods of these studies presents no reliable target for mobile devices to offer automated help-the feasibility across studies suggests the potential to use these data today towards personalising care. As more unified digital phenotyping research evolves and scales to larger sample sizes, student mental health centres may consider integrating these data into their clinical practice for college students.
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http://dx.doi.org/10.1136/ebmental-2020-300180DOI Listing
November 2020

Digital Opportunities for Outcomes in Recovery Services (DOORS): A Pragmatic Hands-On Group Approach Toward Increasing Digital Health and Smartphone Competencies, Autonomy, Relatedness, and Alliance for Those With Serious Mental Illness.

J Psychiatr Pract 2020 03;26(2):80-88

HOFFMAN, WISNIEWSKI, HAYS, HENSON, VAIDYAM, HENDELL, KESHAVAN, TOROUS: Department of Psychiatry, Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

Digital health technologies such as smartphones present the potential for increased access to care and on-demand services. However, many patients with serious mental illnesses (eg, schizophrenia) have not been offered the digital health training necessary to fully utilize these innovative approaches. To bridge this digital divide in knowledge and skills, we created a hands-on and interactive training program grounded in self-determination theory, technology use cases, and the therapeutic alliance. This article introduces the need and theoretical foundation for and the experience of running the resulting Digital Opportunities for Outcomes in Recovery Services (DOORS) group in the setting of 2 programs: a first-episode psychosis program and a clubhouse for individuals with serious mental illness. The experience of running these 2 DOORS groups resulted in 2 publicly available, free training manuals to empower others to run such groups and adapt them for local needs. Future work on DOORS will expand the curriculum to best support digital health needs and increase equity of access to and knowledge and skills related to technology use in serious mental illness.
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http://dx.doi.org/10.1097/PRA.0000000000000450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7135933PMC
March 2020

Comparison of psychiatric comorbidities and impact on quality of life in patients with epilepsy or psychogenic nonepileptic spells.

Epilepsy Behav 2020 01 20;102:106649. Epub 2019 Nov 20.

Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, TX 75390, USA. Electronic address:

Objectives: Psychiatric comorbidity is common in people with epilepsy (PWE) and psychogenic nonepileptic spells (PNES). These comorbidities can be detrimental to quality of life (QOL) and are often underdiagnosed and undertreated. Some types of epilepsy, such as focal temporal lobe epilepsy (TLE), have been associated with higher rates of psychiatric comorbidity. This study examined the impact of psychiatric comorbidity on QOL in patients admitted to two level 4 epilepsy monitoring units (EMUs).

Methods: In this prospective observational study, 200 patients admitted to two level 4 EMUs completed standardized surveys including the Quality of Life in Epilepsy (QOLIE-31-P), Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire (PHQ-9), and Beck Depression Inventory-II (BDI-II). Hierarchal multiple regression was performed to assess impact on QOL.

Results: Of the 200 participants, 113 had a diagnosis of epilepsy, 36 had a diagnosis of PNES, and 51 were excluded for nondiagnostic evaluation or dual diagnosis. Of those with epilepsy, 65 had TLE, 28 had focal extratemporal lobe epilepsy (ETLE), and 20 had nonfocal epilepsy. Patients with PNES had higher self-reported anxiety and depression levels (GAD-7: p = 0.04, PHQ-9: p < 0.01; BDI-II: p < 0.01) but similar QOL to PWE (p = 0.78). Using hierarchal multiple regression, symptoms of anxiety and depression were significant predictors of lower QOL in PWE but not in patients with PNES. There was no difference in QOL in those with ETLE and TLE.

Conclusions: Our findings suggest that self-reported anxiety and depression symptoms are common in patients admitted to level 4 EMUs regardless of diagnosis and play an important role in predicting QOL in PWE. Our findings emphasize the importance of routinely screening all EMU patients for psychiatric comorbidity.
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http://dx.doi.org/10.1016/j.yebeh.2019.106649DOI Listing
January 2020

Assessing Cognition Outside of the Clinic: Smartphones and Sensors for Cognitive Assessment Across Diverse Psychiatric Disorders.

Psychiatr Clin North Am 2019 12 25;42(4):611-625. Epub 2019 Sep 25.

Division of Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215, USA. Electronic address:

Traditionally, the assessment of cognition and the administration of cognitive therapies has been performed in the clinic, but with modern technology, this clinic-centric view is changing. This article explores the landscape of digital devices used to measure cognition in settings outside the clinic. These devices range in mobility from user-friendly mobile devices to setting-specific devices able to provide powerful, robust cognitive therapy and living assistance in the comfort of a patient's home. Although these methods remain in early stages of developmental, initial studies suggest they may prove useful in treating patients with serious mental illnesses in a widespread clinical setting.
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http://dx.doi.org/10.1016/j.psc.2019.08.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299150PMC
December 2019

Response to: Assessing sexual dysfunction in men with epilepsy: A need for specific tools!

Epilepsy Behav 2019 10 24;99:106278. Epub 2019 Jul 24.

UT Southwestern Medical Center, Dallas, TX, USA. Electronic address:

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http://dx.doi.org/10.1016/j.yebeh.2019.04.031DOI Listing
October 2019

Response to: Assessing sexual dysfunction in men with epilepsy: A need for specific tools!

Epilepsy Behav 2019 10 24;99:106278. Epub 2019 Jul 24.

UT Southwestern Medical Center, Dallas, TX, USA. Electronic address:

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http://dx.doi.org/10.1016/j.yebeh.2019.04.031DOI Listing
October 2019

Performance of the International Index of Erectile Function tool in men with epilepsy.

Epilepsy Behav 2019 05 17;94:78-81. Epub 2019 Mar 17.

University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-8855, United States of America.

Background: Approximately 18 million men suffer from some type of erectile dysfunction (ED), which is primarily attributed to age, comorbid health conditions, or medications. Men with epilepsy encounter all of these issues, yet ED literature and research in men with epilepsy is not yet robust. The purpose of this study was to test the utility of a validated ED screening tool in a population of men with epilepsy, as well as to assess additional parameters that may contribute to ED in this specific patient population. The secondary aim of this study was to determine the prevalence of noncompliance of epilepsy medication which may be due to a perceived relationship with ED.

Methods: This was a prospective pilot study to validate the International Index of Erectile Function (IIEF) in men with epilepsy. Enrolled men, between the ages of 18-45 years, were given an anonymous online survey that included the IIEF, as well as additional elements pertinent to their seizures and related treatment, including medication compliance.

Results: A total of 164 men completed the IIEF survey. Of these, 28% of respondents indicated the presence of ED, for which specific treatment might be warranted. The IIEF has 5 subscales; mean scores for each subscale are the following: ED 17.48/30, orgasmic function 6.2/10, sexual desire 6.72/10, intercourse satisfaction 8.98/15, and overall satisfaction 5.18/10. Four additional variables were added to specify the needs of men with epilepsy.

Conclusion: The IIEF can be administered to men with epilepsy. The addition of specific targeted questions in this patient population may also provide better understanding and facilitate an open dialog about how male sexual function relates to epilepsy and/or treatment thereof.
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http://dx.doi.org/10.1016/j.yebeh.2019.01.044DOI Listing
May 2019

Diagnostic Yield of 2-Hour EEG Is Similar With 30-Minute EEG in Patients With a Normal 30-Minute EEG.

J Clin Neurophysiol 2019 May;36(3):204-208

Department of Neurology and Neurotherapeutics, University of Texas Southwestern, Dallas, U.S.A.

Purpose: Current literature suggests that longer duration of EEG recording increases the yield of detecting interictal epileptiform discharges. However, optimal duration for a repeat study in patients with initially normal 30-minute EEG is not clear. Thus, the purpose of this study is to determine whether a 2-hour EEG has a diagnostic advantage over a routine 30-minute EEG in detecting epileptiform abnormalities in patients who had a first normal 30-minute EEG.

Methods: This is a single-center, retrospective study done at UT Southwestern Medical Center at Dallas and Parkland Memorial Hospital. The data from 1997 to 2015 were extracted from the existing EEG report database for patients who had a first normal 30-minute EEG recording. EEG was interpreted by board-certified clinical neurophysiologists, who classified each EEG as normal or abnormal, with relevant subsequent subclassification.

Results: Over 18 years, a total of 12,425 individual 30-minute EEGs were performed. Of these, 1,023 patients had at least one repeated EEG after the first normal EEG. Among these patients, 763 had a 30-minute EEG as the second study and 260 had a 2-hour EEG as the second study. The yield of epileptiform discharges was 3.3% in the 30-minute EEG group and 4.2% in the 2-hour EEG group (P = 0.5) in the repeating studies.

Conclusions: Two-hour EEG has a similar yield as 30-minute EEG to detect epileptiform discharges in patients with a normal 30-minute EEG.
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http://dx.doi.org/10.1097/WNP.0000000000000567DOI Listing
May 2019

Neurological Autoantibody Prevalence in Epilepsy of Unknown Etiology.

JAMA Neurol 2017 04;74(4):397-402

Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas2Department of Neurology, Parkland Health and Hospital System, Dallas, Texas.

Importance: Autoimmune epilepsy is an underrecognized condition, and its true incidence is unknown. Identifying patients with an underlying autoimmune origin is critical because these patients' condition may remain refractory to conventional antiseizure medications but may respond to immunotherapy.

Objective: To determine the prevalence of neurological autoantibodies (Abs) among adult patients with epilepsy of unknown etiology.

Design, Setting, And Participants: Consecutive patients presenting to neurology services with new-onset epilepsy or established epilepsy of unknown etiology were identified. Serum samples were tested for autoimmune encephalitis Abs as well as thyroperoxidase (TPO) and glutamic acid decarboxylase 65 (GAD65) Abs. An antibody prevalence in epilepsy (APE) score based on clinical characteristics was assigned prospectively. Data were collected from June 1, 2015, to June 1, 2016.

Main Outcomes And Measures: Presence of neurological Abs. A score based on clinical characteristics was assigned to estimate the probability of seropositivity prior to antibody test results. Good seizure outcome was estimated on the basis of significant reduction of seizure frequency at the first follow-up or seizure freedom.

Results: Of the 127 patients (68 males and 59 females) enrolled in the study, 15 were subsequently excluded after identification of an alternative diagnosis. Serum Abs suggesting a potential autoimmune etiology were detected in 39 (34.8%) cases. More than 1 Ab was detected in 7 patients (6.3%): 3 (2.7%) had TPO-Ab and voltage-gated potassium channel complex (VGKCc) Ab, 2 (1.8%) had GAD65-Ab and VGKCc-Ab, 1 had TPO-Ab and GAD65-Ab, and 1 had anti-Hu Ab and GAD65-Ab. Thirty-two patients (28.6%) had a single Ab marker. Among 112 patients included in the study, 15 (13.4%) had TPO-Ab, 14 (12.5%) had GAD65-Ab, 12 (10.7%) had VGKCc (4 of whom were positive for leucine-rich glioma-inactivated protein 1 [LGI1] Ab), and 4 (3.6%) had N-methyl-D-aspartate receptor (NMDAR) Ab. Even after excluding TPO-Ab and low-titer GAD65-Ab, Abs strongly suggesting an autoimmune cause of epilepsy were seen in 23 patients (20.5%). Certain clinical features, such as autonomic dysfunction, neuropsychiatric changes, viral prodrome, faciobrachial dystonic spells or facial dyskinesias, and mesial temporal sclerosis abnormality on magnetic resonance imaging, correlated with seropositivity. The APE score was a useful tool in predicting positive serologic findings. Patients who were Ab positive were more likely to have good seizure outcome than were patients with epilepsy of unknown etiology (15 of 23 [65.2%] vs 24 of 89 [27.0%]; odds ratio, 4.8; 95% CI, 1.8-12.9; P = .002). In patients who were seropositive, reduction in seizure frequency was associated with use of immunomodulatory therapy.

Conclusions And Relevance: Among adult patients with epilepsy of unknown etiology, a significant minority had detectable serum Abs suggesting an autoimmune etiology. Certain clinical features (encoded in the APE score) could be used to identify patients with the highest probability of harboring neurological Abs.
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http://dx.doi.org/10.1001/jamaneurol.2016.5429DOI Listing
April 2017

Evaluation of positive and negative predictors of seizure outcomes among patients with immune-mediated epilepsy: a meta-analysis.

Ther Adv Neurol Disord 2016 Sep 4;9(5):369-77. Epub 2016 Jul 4.

Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, TX, USA.

Background: The objective of this study was to analyze published literature on autoimmune epilepsy and assess predictors of seizure outcome.

Methods: From PubMed and EMBASE databases, two reviewers independently identified publications reporting clinical presentations, management and outcomes of patients with autoimmune epilepsy. A meta-analysis of 46 selected studies was performed. Demographic/clinical variables (sex, age, clinical presentation, epilepsy focus, magnetic resonance imaging [MRI] characteristics, time to diagnosis and initiation of immunomodulatory therapy, and type of immunomodulatory therapy) were compared between two outcome groups (responders and nonresponders). Clinical response was defined as >50% reduction in seizure frequency. Unstandardized effect sizes were collected for the studies for responder and nonresponder groups. Sample size was used as the weight in the meta-analysis. The random effects model was used to account for heterogeneity in the studies.

Results: The 46 reports included 186 and 96 patients in responder and nonresponder groups respectively. Mean age of the responders and nonresponders was 43 and 31 years (p < 0.01). Responders were more likely to have cell-surface antibodies (68% versus 39%, p < 0.05), particularly voltage-gated potassium channel complex antibodies (p < 0.01). Mean duration from symptom onset to diagnosis, and symptom onset to initiation of immunomodulation was significantly lower among the responders (75 versus 431 days, p < 0.05, and 80 versus 554, p < 0.01, respectively). There was no outcome difference based on gender, MRI characteristics, seizure type, type of acute immunomodulatory therapy, or use of chronic immunomodulation.

Conclusions: Among published cases to date, older age, presence of cell-surface antibodies, early diagnosis and immunomodulatory treatment are associated with better seizure outcomes among patients with autoimmune epilepsy.
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http://dx.doi.org/10.1177/1756285616656295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994784PMC
September 2016

Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.

Clin Ther 2016 Jul 7;38(7):1726-1737.e1. Epub 2016 Jun 7.

XenoPort, Inc, Santa Clara, California.

Purpose: Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe primary RLS.

Methods: Data were pooled from the randomized, double-blind, placebo-controlled, 12-week studies of XP052, XP053, and XP081 for adults who received GEn (600 or 1200 mg) or placebo once daily. Adults had primary RLS, IRLS total score ≥15, and RLS symptoms >15 days during the month before screening and for ≥4 of the 7 consecutive evenings at baseline. End points included mean change from baseline to week 12 in individual IRLS and post-sleep questionnaire (PSQ) items. For IRLS items, least squares mean treatment differences were calculated from a mixed model for repeated measures. For PSQ items, Cochran-Mantel-Haenszel row mean scores tests with integer scoring were used. Correlations between IRLS and PSQ items were assessed by Spearman's rank coefficients. Safety profile outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs.

Findings: The modified intent-to-treat population included 671 patients (GEn 600 mg = 161; GEn 1200 mg = 266; placebo = 244). GEn significantly improved mean [SE] differences versus placebo for all IRLS items at week 12, including severity of sleep disturbance (GEn 600 mg, -0.4 [0.10]; GEn 1200 mg, -0.4 [0.09]), daytime tiredness (-0.4 [0.09]; -0.4 [0.08]), RLS severity (-0.4 [0.10]; -0.3 [0.08]), impact on daily affairs (-0.3 [0.07]; -0.3 [0.07]), and mood disturbance (-0.2 [0.07]; -0.3 [0.06]); all P<0.001). For PSQ items, significant (P<0.01) improvements occurred with both GEn doses versus placebo at week 12. The correlations between IRLS and PSQ items for change from baseline to week 12 were moderate to strong, and all correlations were significant (P<0.001). The most frequent TEAEs were somnolence (GEn 600 mg, 20%; GEn 1200 mg, 23%; placebo, 5%) and dizziness (GEn 600 mg, 14%; GEn 1200 mg, 22%; placebo, 5%).

Implications: GEn significantly improved individual IRLS items and sleep disturbance versus placebo. Correlations between IRLS and PSQ items were moderate to strong. This was not a formal meta-analysis and was not powered to compare the GEn doses. Nevertheless, our study finds that the benefits of GEn extend to individual IRLS items and supports the importance of sleep quality in RLS treatment. ClinicalTrials.gov identifiers: NCT00298623, NCT00365352, and NCT01332305.
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http://dx.doi.org/10.1016/j.clinthera.2016.05.008DOI Listing
July 2016

Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome.

Sleep Med 2016 03 14;19:50-6. Epub 2015 Nov 14.

XenoPort, Inc., 3410 Central Expressway, Santa Clara, CA 95051, USA.

Aim: Assess efficacy and tolerability of gabapentin enacarbil (GEn) in adults with severe primary restless legs syndrome (RLS).

Methods: We pooled data from three 12-week, double-blind, placebo-controlled, randomized trials (NCT00298623, NCT00365352, NCT01332305) across GEn 600-mg, GEn 1200-mg, and placebo treatment groups for severe primary RLS (baseline International Restless Legs Scale (IRLS) total score ≥24). Co-primary end points at week 12 were mean change from baseline in IRLS total score and proportion of responders ("much"/very much" improved) on the investigator-rated Clinical Global Impression - Improvement (CGI-I) Scale. Outcomes for individual IRLS items (eg, sleep, mood, quality of life, pain, safety) were assessed.

Results: A total of 309 patients had severe primary RLS (placebo, n = 110; GEn 600 mg, n = 80; GEn 1200 mg, n = 119). GEn 600 mg and 1200 mg significantly improved least-squares mean IRLS total scores versus placebo at week 12 (placebo, -12.3; GEn 600 mg, -16.3; GEn 1200 mg, -18.0; treatment difference vs. placebo, both p <0.01). Significantly more patients with severe primary RLS treated with GEn 600 mg (64%) and 1200 mg (74%) were CGI-I responders at week 12 versus placebo (42%; p <0.01 for both GEn doses). Both GEn doses led to significant improvements in the other outcomes explored versus placebo at week 12. The most frequent treatment-emergent adverse events (TEAEs) were somnolence (GEn, 21-24%; placebo, 3%) and dizziness (GEn, 14-19%; placebo, 3%).

Conclusions: GEn (600 mg or 1200 mg) once daily significantly improved RLS symptoms and consequences of these symptoms in severe primary RLS. The most frequent TEAEs were somnolence and dizziness.
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http://dx.doi.org/10.1016/j.sleep.2015.11.002DOI Listing
March 2016

Predictors of Postoperative Seizure Recurrence: A Longitudinal Study of Temporal and Extratemporal Resections.

Epilepsy Res Treat 2016 16;2016:7982494. Epub 2016 Mar 16.

Department of Neurosurgery, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.

Objective. We investigated the longitudinal outcome of resective epilepsy surgery to identify the predictors of seizure recurrence. Materials and Methods. We retrospectively analyzed patients who underwent resections for intractable epilepsy over a period of 7 years. Multiple variables were investigated as potential predictors of seizure recurrence. The time to first postoperative seizure was evaluated using survival analysis and univariate analysis at annual intervals. Results. Among 70 patients, 54 (77%) had temporal and 16 (23%) had extratemporal resections. At last follow-up (mean 48 months; range 24-87 months), the outcome was Engel class I in 84% (n = 59) of patients. Seizure recurrence followed two patterns: recurrence was "early" (within 2 years) in 82% of patients, of whom 83% continued to have seizures despite optimum medical therapy; recurrence was "late" (after 2 years) in 18%, of whom 25% continued to have seizures subsequently. Among the variables of interest, only resection site and ictal EEG remained as independent predictors of seizure recurrence over the long term (p < 0.05). Extratemporal resection and discordance between ictal EEG and resection area were associated with 4.2-fold and 5.6-fold higher risk of seizure recurrence, respectively. Conclusions. Extratemporal epilepsy and uncertainty in ictal EEG localization are independent predictors of unfavorable outcome. Seizure recurrence within two years of surgery indicates poor long-term outcome.
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http://dx.doi.org/10.1155/2016/7982494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4812270PMC
April 2016

Temporal lobe volume predicts Wada memory test performance in patients with mesial temporal sclerosis.

Epilepsy Res 2016 Feb 28;120:25-30. Epub 2015 Nov 28.

Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-8508, USA. Electronic address:

The Wada test is widely used in the presurgical evaluation of potential temporal lobectomy patients to predict postoperative memory function. Expected asymmetry (EA), defined as Wada memory lateralized to the nonsurgical hemisphere, or a higher score after injection of the surgical hemisphere would be considered favorable in terms of postoperative memory outcome. However, in some cases, nonlateralized memory (NM) results, with no appreciable asymmetry, may occur because of impaired scores after both injections, often leading to denial of surgery. The reason for such nonlateralized Wada memory in patients with intractable temporal lobe epilepsy (TLE) remains unclear. Given that quantitative morphometric magnetic resonance imaging studies in TLE patients have shown bilateral regional atrophy in temporal and extratemporal structures, we hypothesized that the volume loss in contralateral temporal structures could contribute to nonlateralized Wada memory performance. To investigate this, we examined the relationship between the volume changes of temporal structures and Wada memory scores in patients with intractable TLE with mesial temporal sclerosis (MTS) using an age- and gender-matched control group. Memory was considered nonlateralized if the absolute difference in the total correct recall scores between ipsilateral and contralateral injections was <11%. Among 21 patients, Wada memory was lateralized in 15 and nonlateralized in 6 patients, with all the nonlateralized scores being observed in left TLE. The recall scores after ipsilateral injection were significantly lower in patients with an NM profile than an EA profile (23 ± 14% vs. 59 ± 18% correct recall, p ≤ 0.001). However, the recall scores after contralateral injection were low but similar between the two groups (25 ± 17% vs. 25 ± 15% correct recall, p=0.97). Compared to controls, all the patients showed greater volume loss in the temporal regions. However, patients with a NM profile showed significantly more volume loss than those with a lateralized memory profile in both contralateral and ipsilateral temporal regions (p<0.05). Left hemispheric Wada memory performance correlated positively with the size of the left mesial and neocortical temporal structures (r=0.49-0.63, p=0.005-0.04). Our study suggests that volume loss in the nonsurgical temporal structures is associated with nonlateralized Wada memory results in patients with intractable TLE.
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http://dx.doi.org/10.1016/j.eplepsyres.2015.11.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4740193PMC
February 2016

Retrospective case series of the clinical features, management and outcomes of patients with autoimmune epilepsy.

Seizure 2015 Jul 30;29:143-7. Epub 2015 Apr 30.

Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, United States.

Purpose: Analyze clinical and electrographic characteristics of patients with autoimmune epilepsy, and evaluate the effect of early diagnosis and treatment on reduction of seizure frequency.

Methods: Observational retrospective case series, conducted using electronic medical data from two teaching hospitals. Clinical data was collected from 2008 to 2013. Cases of new onset seizures were selected based on the presence of laboratory evidence of autoimmunity.

Results: 34 hospitalized patients who presented predominantly due to seizures with concern for autoimmune etiology were identified. Mean age of patients was 44.94 years and 64.7% were males. Autoimmune antibodies were detected in 76.5% (26) of patients as follows: VGKc (8); NMDA-R (7); anti-thyroid (5); GAD (4); GABAB (2). 22 patients had unilateral temporal lobe onset and 4 had bilateral temporal lobe onset, while 8 had extra-temporal onset/multiple ictal foci. Median number of seizures during initial prolonged vEEG monitoring was 8 (range 0-48); median number of anti-seizure medications used was 2 (range 1-5). 9 patients had an underlying malignancy. 94.1% (32) patients received immunomodulation, as follows: high dose corticosteroids (96.8%), plasmapheresis (62.5%), IVIG (34.4%), rituximab (21.8%), mycophenolate (15.6%), cyclophosphamide (12.5%). 63.3% (19) participants achieved ≥ 50% seizure reduction (Responder Rate) at first clinic visit. Patients without malignancy had better seizure control (p < 0.05). Time from symptom onset to diagnosis (p < 0.005) and symptom onset to immunomodulation (p < 0.005) was significantly lower among patients who achieved responder rate (RR).

Conclusion: This study highlights certain important clinical and electrographic aspects of autoimmune epilepsy, and the significance of early diagnosis and initiation of immunomodulatory therapy.
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http://dx.doi.org/10.1016/j.seizure.2015.04.007DOI Listing
July 2015

Anterior corpus callosotomy combined with anterior temporal resection with amygdalohippocampectomy: outcome in a patient with congenital bilateral perisylvian syndrome.

Turk Neurosurg 2014 ;24(1):70-4

The Second Affiliated Hospital, Zhejiang University College of Medicine, Department of Neurosurgery, Hangzhou, China.

Congenital bilateral perisylvian syndrome (CBPS) is characterized by epilepsy, cognitive deficits, pseudobulbar palsy and diplegia of the facial, pharyngeal and masticatory muscles. Epilepsy has been described in nearly 90% of affected patients. The epilepsy is usually severe and pharmacoresistant in about 55 percent of CBPS patients. Until now, only 12 cases of surgical treatment on CBPS have been reported; the surgical treatment is usually corpus callosotomy. In this paper, we describe a previously unreported combination of anterior corpus callosotomy plus anterior temporal lobectomy with amygdalohippocampectomy for a patient with CBPS, resulting in a satisfactory clinical outcome. Based on this case, we suggest that palliative focal resective surgery combined with anterior corpus callosotomy should be considered when a predominance of the epileptiform discharges suggests focal onset in patients with CBPS. Meanwhile, the clinical decision to adopt this combination surgery must be based on a thorough pre-surgical evaluation, and should take into account the clinical, radiological, and EEG features.
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http://dx.doi.org/10.5137/1019-5149.JTN.6362-12.1DOI Listing
October 2014

Mimetic automatisms expressing a negative affect in two patients with temporal lobe epilepsy.

Epilepsy Behav 2011 Mar;20(3):572-8

Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.

Ictal automatisms of fear or sadness, of which the patient is unaware and which are not preceded by a corresponding emotion, have not been well characterized. Of 557 patients admitted for video/EEG monitoring, 2 (0.36%) were identified who had automatisms of fear and sadness. One patient was found to have a sudden ictal expression of sadness of which he was not aware. The second patient showed a sudden fearful expression, followed by oral automatisms, staring, and amnesia for the event. Both patients had left mesial temporal lobe epilepsy. The patient with ictal fear underwent further invasive monitoring and became seizure free after a limited mesial temporal resection. The mesial temporal structures not only mediate emotional experiences, but can also activate stereotyped expressions of fear or sadness without the patient's awareness, arguing for an efferent pathway for expressing negative affects within the mesial temporal lobe.
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http://dx.doi.org/10.1016/j.yebeh.2011.01.001DOI Listing
March 2011

Sudden unexpected death in epilepsy.

Curr Neurol Neurosci Rep 2010 Jul;10(4):319-26

Jefferson Comprehensive Epilepsy Center, Department of Neurology, Jefferson Medical College, 900 Walnut Street, Suite 200, Philadelphia, PA 19107, USA.

Sudden unexpected death in epilepsy (SUDEP) is a significant cause of death for people with epilepsy. Recent research suggests that multiple factors may contribute and that both cardiac and respiratory mechanisms are involved. Both human and animal data suggest that specific genetic factors might play a role in some cases. Recent animal data suggest that serotonin might affect respiratory mechanisms and may be involved. Both cardiac and respiratory abnormalities are more likely with generalized tonic-clonic seizures. Uncontrolled epilepsy, particularly with generalized tonic-clonic seizures, appears to be the most highly associated modifiable risk factor for SUDEP.
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http://dx.doi.org/10.1007/s11910-010-0116-4DOI Listing
July 2010