Validation of the Georgian version of a Stigma Scale of Epilepsy.

INTRODUCTION: Stigma Scale of Epilepsy (SSE), initially developed in Brazil, is accepted worldwide as a sensitive tool for assessing epilepsy-related stigma. We adapted and validated a Georgian version of SSE. MATERIALS AND METHODS: The SSE originated in Brazil and was translated into Georgian by three independent experts through forward and backward translation. The final version was generated for validation after handling gross or conceptual inconsistencies between the source and the new format. We used Cronbach's alpha to assess the internal consistency of the Georgian version of SSE. To explore the construct of SSE subscales in the Georgian version, we used principal components and factor analysis. Varimax rotation was applied. The Kaiser-Meyer-Olkin Measure and Bartlett's test of sphericity were employed to assess the sampling adequacy. A probability <0.05 was considered statistically significant. RESULTS: 87 adults, 32 (37 %) with epilepsy and 55 (63 %) without epilepsy were enrolled. The overall mean score of SSE was 19.5 (SD 10.1; min. 2, max. 53), and the differences between people with [20.7 (SD 8.9; min. 2, max. 53)] and without epilepsy [17.5 (SD 10.4; min. 3, max. 42)] were not statistically significant. Cronbach's alpha for the overall sample was 0.854; for the epilepsy cohort it was 0.876, and for individuals without epilepsy 0.823, indicating good SSE internal consistency. Kaiser-Meyer-Olkin Measure was 0.705 and Bartlett's test of sphericity was 926.2 (df 276; p < 0.001), suggesting acceptable sample adequacy. DISCUSSION: The Georgian version of the SSE is a valid and reliable measurement tool for assessing epilepsy-related stigma determinants among the country's population.

Implementing the SCORE system improves the quality of clinical EEG reading.

Objective: To assess whether implementing the freeware version of the SCORE EEG system (Standardized Computer-based Organized Reporting of EEG) leads to improvement in the quality of clinical EEG reading, and whether EEG reports in SCORE EEG are understood and accepted by the referring physicians. Methods: We generated EEG reports in the conventional, free-text style and then using SCORE EEG, in consecutive patients referred to routine EEG. We used the Georgian translation in the SCORE EEG Free Edition. We pre-defined quality indicators consisting of a list of 24 key features that need to be addressed in EEG reports. We compared these quality indicators in free-text reports with SCORE EEG. In addition, EEG reports in SCORE EEG format were assessed by ten referring physicians, who evaluated their usability on a 7-point Likert scale. Results: We included and evaluated EEG reports from 157 patients (80 female; age: 1-75 years; median: 28 years). Fourteen features were reported exclusively in SCORE EEG, four were reported significantly more often in SCORE EEG than in free-text format, and six features were reported equally often in SCORE EEG and in free-text format. Usability aspects of SCORE EEG were highly rated by the referring physicians (median 6-7 on the 7-point Likert scale). Conclusions: The structured system of EEG reporting in SCORE EEG helped the experts reading clinical EEG to cover the important aspects and increase the quality of clinical EEG reports. Significance: Implementing the freeware version of SCORE EEG in underprivileged areas will help improving management of patients with epilepsy.

Automated detection of absence seizures using a wearable electroencephalographic device: a phase 3 validation study and feasibility of automated behavioral testing.

OBJECTIVE: Our primary goal was to measure the accuracy of fully automated absence seizure detection, using a wearable electroencephalographic (EEG) device. As a secondary goal, we also tested the feasibility of automated behavioral testing triggered by the automated detection. METHODS: We conducted a phase 3 clinical trial (NCT04615442), with a prospective, multicenter, blinded study design. The input was the one-channel EEG recorded with dry electrodes embedded into a wearable headband device connected to a smartphone. The seizure detection algorithm was developed using artificial intelligence (convolutional neural networks). During the study, the predefined algorithm, with predefined cutoff value, analyzed the EEG in real time. The gold standard was derived from expert evaluation of simultaneously recorded full-array video-EEGs. In addition, we evaluated the patients' responsiveness to the automated alarms on the smartphone, and we compared it with the behavioral changes observed in the clinical video-EEGs. RESULTS: We recorded 102 consecutive patients (57 female, median age = 10 years) on suspicion of absence seizures. We recorded 364 absence seizures in 39 patients. Device deficiency was 4.67%, with a total recording time of 309 h. Average sensitivity per patient was 78.83% (95% confidence interval [CI] = 69.56%-88.11%), and median sensitivity was 92.90% (interquartile range [IQR] = 66.7%-100%). The average false detection rate was .53/h (95% CI = .32-.74). Most patients (n = 66, 64.71%) did not have any false alarms. The median F1 score per patient was .823 (IQR = .57-1). For the total recording duration, F1 score was .74. We assessed the feasibility of automated behavioral testing in 36 seizures; it correctly documented nonresponsiveness in 30 absence seizures, and responsiveness in six electrographic seizures. SIGNIFICANCE: Automated detection of absence seizures with a wearable device will improve seizure quantification and will promote assessment of patients in their home environment. Linking automated seizure detection to automated behavioral testing will provide valuable information from wearable devices.

A six-year longitudinal study of neurocognitive problems in children with epilepsy.

INTRODUCTION: This study describes the specific neuropsychological abnormalities among children with epilepsy (CH-E) living in Georgia. METHODS: A cohort of CH-E and children without epilepsy (CH-NoE), aged 6-13 years, admitted to the epilepsy center of the Institute of Neurology and Neuropsychology from 1st January 2010 to 31st December 2015, was selected and investigated with a structured protocol. Neurological/epileptological assessments were made and neuropsychological testing was done on all study subjects. RESULTS: Abnormalities in praxis, verbal functions, verbal learning, visual-spatial matching, visual-motor ability, and fine motor skills, working memory, and phonological memory span were often revealed in CH-E as compared to CH-NoE. Early age of seizure onset, epilepsy duration, and anti-seizure medication (ASM) use, in combination with brain structural abnormalities on neuroimaging, and structural etiology were independent predictors of impaired functioning in various neuropsychological domains. DISCUSSION: More than half of children with epilepsy have a variety of cognitive impairments, which may increase with ASM therapy, especially when the cause of seizures is structural damage to the brain. Therefore, in the process of diagnosing epilepsy, evaluation of cognitive functions should become an integral part to ensure effective management of the disorder.

Initiating a new national epilepsy surgery program: Experiences gathered in Georgia.

Surgery is the most effective therapeutic approach for medically refractory epilepsies and a safe and cost-efficient treatment in terms of long-term expenses of direct, indirect, and intangible costs. Georgia is a Caucasian low- to middle-income country with a remarkable effort to deal with epileptic diseases, but without an appropriate epilepsy surgery program. To address the needs for such a service in this country, two joint German-Georgian projects were initiated in 2017 and 2019. In the framework of these projects, a productive exchange program involving German and Georgian experts was undertaken in the past two years. This program included training and mentoring for Georgian clinical colleagues, as well as joint case conferences and workshops with the aim of optimizing presurgical diagnostics and preparing for an epilepsy surgery program in Georgia. Finally, a postsurgical medium- and long-term follow-up scheme was organized as the third component of this comprehensive approach. As a result of our efforts, the first patients underwent anterior temporal lobectomy and all of them remain seizure-free up to the present day. Hence, epilepsy surgery is not only feasible, but also already available in Georgia. In this report, we aim to share our experiences in the initiation and implementation of surgical epilepsy intervention in Georgia and illustrate our recent endeavor and achievements.

Validation of a Georgian version of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).

INTRODUCTION: This study aimed to validate a Georgian version of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E). The distribution of psychiatric disorders was assessed among patients with epilepsy. METHODS: One hundred and thirty consecutive adult patients with epilepsy completed the NDDI-E and the Beck Depression Inventory (BDI). All patients were further assessed by a qualified psychiatrist. RESULTS: In 31 (23.8%) patients, a diagnosis of major depression was revealed. The internal consistency of the NDDI-E was 0.695. Receiver operating characteristics (ROC) showed an area under the curve of 0.975. A cutoff score of ≥16 resulted in a sensitivity of 0.90 and a specificity of 0.939. The screening questionnaire showed a significantly positive correlation with BDI scores (Spearman's rho - 0.684), indicating good concurrent validity. DISCUSSION: The Georgian version of the NDDI-E is a reliable tool for the detection of depressive disorders in individuals with epilepsy.

Cognitive functions in children exposed to antiepileptic drugs in utero - Study in Georgia.

OBJECTIVE: The cognitive teratogenicity of antiepileptic drugs (AEDs) has gained increasing attention in the last decade. The objective of the current study was to assess the effects of AED fetal exposure on the cognitive development of children of mothers with epilepsy from Georgia in a controlled study taking into consideration major confounding factors. METHODS: A prospective cohort group was formed from children and mothers registered in the Georgian National AED-Pregnancy Registry. The study group's age- and gender-matched control children without fetal AED exposure were selected retrospectively. The Intelligence Quotient (IQ) using the Wechsler Adult Intelligence Scale - revised (WAIS-R) was assessed in mothers. The Wechsler Preschool and Primary Scale of Intelligence (WPPSI-4) were used to assess intellectual functioning for children of both study and control groups. Linear regression analysis was performed to detect association of AED exposure on the cognitive performance of children. RESULTS: In total, 100 children aged 36 to 72months were evaluated. The IQ of WWE was significantly lower compared to women without epilepsy in all modalities. Exposure to valproate (VPA) (n=18) was associated with lowest cognitive performance regarding Full Scale IQ (FSIQ) (ß, -12.04; p=0.006) and verbal comprehension (VCI) (ß, -8.89; p=0.019). Maternal FSIQ, maternal performance IQ (PIQ), and child's age at first phrases were independent factors associated with the cognitive development of children. CONCLUSIONS: Multivariate analysis showed VPA to be an independent predictor for decreased cognitive performance. Maternal FSIQ, PIQ, and child developmental achievements were significant confounders for cognitive performance in children.

Focal EEG features and therapeutic response in patients with juvenile absence and myoclonic epilepsy.

OBJECTIVE: To investigate the characteristics of focal EEG features in patients with juvenile absence epilepsy (JAE) and juvenile myoclonic epilepsy (JME), and to assess their possible influence on therapeutic response. METHODS: Focal EEG features were prospectively scored in 168 consecutive patients. Ninety-six patients were drug-naïve and 72 patients were already on antiepileptic drugs (AEDs): 38 on adequate medication and 34 on inadequate medication. Therapeutic response was assessed one year after starting adequate therapy. RESULTS: One-hundred-eighteen patients (70.2%) had focal EEG features: 89 patients (53%) had focal epileptiform discharges, and 80 patients (47.6%) had focal slowing. Most often, these were multifocal and localized in frontal and temporal regions. Among patients already on AEDs, patients with focal EEG features were more often treated with inadequate medication due to misdiagnosis, than patients without focal features. Data on therapeutic response were available for 118 patients; most of them (90.7%) were seizure free. None of the focal EEG features affected therapeutic response. CONCLUSION: Focal EEG features are common in patients with JME and JAE, but they do not influence the therapeutic response. SIGNIFICANCE: It is important that physicians are aware of the focal EEG features in order to avoid misdiagnosis and inadequate therapy.

Perspectives of epilepsy surgery in resource-poor countries: a study in Georgia.

BACKGROUND: To identify patients with concordant seizure semiology, interictal epileptiform discharges on standard EEG and brain MRI changes to define the patients with pharmacoresistant epilepsy (PRE) who would be suitable for epilepsy surgery according to non-invasive protocol. METHODS: The medical records of the patients with epilepsy seen in Epilepsy Center of Institute of Neurology and Neuropsychology (ECINN) (Tbilisi, Georgia) were reviewed retrospectively. The diagnostic work-up included neurological examination, standard EEG, and MRI. The degree of concordance of the seizure semiology, EEG, and neuroimaging was used to determine the potential candidates for surgery. The probability of seizure freedom rate was estimated based on known predictive values of anatomical, electrophysiological, and semiological characteristics. RESULTS: A total of 83 (25 %) patients met the criteria of PRE. Fourteen (17 %) patients had complete concordance of seizure semiology, MRI, and EEG. Out of these patients, 11 had mesial temporal sclerosis on MRI and three had focal cortical dysplasia (FCD). Estimated seizure-free surgical success rate in this group was 75-95 % without the need for further investigations. Out of 25 (30 %) non-lesional MRI cases, the concordance of seizure semiology and EEG was in nine patients with probable success rate up to 60 %. Thirteen patients (16 %) had discordant EEG and MRI data and were not suitable for surgery without further testing. CONCLUSIONS: A significant portion of PRE patients with concordant anatomical, electrophysiological, and semiological characteristics can be treated surgically in resource-limited countries. Nevertheless, most patients will still require further investigation for proper localization of epileptogenic focus.

Premature mortality in a Georgian cohort of people with epilepsy.

Mortality in people with epilepsy has not previously been estimated in Georgia. We identified a prevalent cohort of people with epilepsy from a tertiary referral centre in Tbilisi, Georgia and attempted to establish survivorship status for all. One-way sensitivity analysis estimating mortality rates in those lost to follow-up was also used. Of 1952 people, 1250 (64%) were located; 93 (7%) had died over a median of 11 years follow up. The main cause specific Proportional Mortality Ratios were: underlying diseases (39%) and accidental death (9%). One SUDEP was confirmed with a further 4 possible, but the cause of death was unknown in 47%. The overall SMR was 1.4, with much higher SMRs (up to 12) in young people. The sensitivity analysis suggested an SMR of 3.0.

Knowledge, attitudes, and stigma towards epilepsy in different walks of life: a study in Georgia.

We conducted a survey to assess public awareness of epilepsy and stigma expression in different social groups in Tbilisi, Georgia. Respondents were divided into those from a medical or paramedical background, those with a nonmedical professional background, and a group with unskilled workers or unemployed individuals. One thousand and sixteen people completed a Knowledge, Attitude and Perception questionnaire. Medical and paramedical professionals had a better general knowledge about epilepsy, its possible causes, and its nature, but their views on treatment and attitudes towards epilepsy were the same or worse when compared to the other groups. Of the respondent, 14% would not let their children play with people with epilepsy, and 75% would not allow their children to marry a person with epilepsy. Nearly a third of teachers considered epilepsy a psychiatric disorder. This suggests a high degree of stigma towards epilepsy in Georgia. Increasing awareness is crucial to ameliorate this.

Mobile telemonitoring for arrhythmias in outpatients in the Republic of Georgia: a brief report of a pilot study.

As the very first trial of mobile telemedicine in the Republic of Georgia, in June-December 2010 we investigated 35 outpatients with different types of arrhythmia (male/female ratio=16/19; 12-80 years old), among them 5 patients with concomitant epilepsy. The control group comprised 7 clinically healthy sportsmen (soccer players, all men; 15-17 years old), during a 30-min velo ergometer stress test. A three-lead electrocardiogram (ECG) loop recorder (Vitaphone BT 3300; Vitasystems GmbH, Mannheim, Germany) was used in automatic mode, using special LRMA software (MDT, Lázne Bohdanec, Czech Republic) and a Nokia (Espoo, Finland) model 6730 Symbian phone. Automatically recorded arrhythmia events were transmitted from the loop recorder by Bluetooth(®) (Bluetooth SIG, Inc., Kirkland, WA) to a phone and then by 3G (through our partner mobile operator, MagtiCom Ltd. [Tbilsi, Georgia]) to the Vitasystems server in Germany and were available to Georgian physicians via e-mail/Internet. Arrhythmias were recorded/monitored during 7-68 h of observation. The number of automatically recorded ECG events varied between 3 and 170 per observation, or 0.4-10.7 hourly. Cases of sinus brady- and tachyarrhythmia, sinus node weakness syndrome, atrial fibrillation, supraventricular tachycardia, supraventricular premature complexes, and ventricular premature complexes were correctly recognized by automatic recognition software and recorded. In 3 patients and 1 sportsman previously unspecified (despite multiple investigations), arrhythmias were recorded: paroxysmal tachycardia (n=1), sinus node weakness syndrome (n=1), and ventricular premature complexes (n=2). In 3 cases (all women) light insomnia and nervousness were reported. In 2 patients with neurosis (both elderly men, 1 with epilepsy) we had to stop investigation prematurely because of anxiety/agitation. Mobile telecardiology represents feasible methodology to monitor arrhythmias in outpatients in Georgia, promoting earlier discharge of non-life-threatening cases, improving patients' comfort of life, and increasing their mobility with enhanced safety. Mobile telehealth might also represent significant cost-saving for insurance companies (this is an ongoing study). Finally, in remote areas mobile telemonitoring of patients will improve quality of care by timely provision of a second opinion in cases when local expertise is not sufficient.

The prevalence and treatment gap of epilepsy in Tbilisi, Georgia.

INTRODUCTION: Data on the prevalence of epilepsy and the extent of its treatment gap are important for planning health care delivery for people with epilepsy. The prevalence of active epilepsy in Georgia prior to the social and political re-organization in the early 1990s was estimated at around 5.7 per 1000. Changes to the social structure of the country may have affected this. There is no previous estimate of the treatment gap. METHODS: A door-to-door survey was carried out using a validated screening questionnaire to determine the prevalence of epilepsy and the extent of the treatment gap amongst a population of about 10,000 people in Tbilisi, the capital of Georgia. The diagnosis of epilepsy amongst those who screened positive was confirmed by a multidisciplinary team. RESULTS: Lifetime prevalence was 11.4/1000. The prevalence of active epilepsy was estimated at 8.8/1000, and 5/1000 had seizures in the previous 12 months. About two thirds of people with active epilepsy had not received appropriate antiepileptic treatment in the month prior to the survey. 89% had focal epilepsy and two thirds had co-morbidity (neurological deficits, behavioral, psychiatric or somatic problems). CONCLUSION: The prevalence of epilepsy was higher than previously estimated and the treatment gap was substantial. Results should inform the planning of epilepsy care delivery in the country.