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1.
Sci Rep ; 14(1): 15823, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38982283

ABSTRACT

People with epilepsy frequently under- or inaccurately report their seizures, which poses a challenge for evaluating their treatment. The introduction of epilepsy health apps provides a novel approach that could improve seizure documentation. This study assessed the documentation performance of an app-based seizure diary and a conventional paper seizure diary. At two tertiary epilepsy centers patients were asked to use one of two offered methods to report their seizures (paper or app diary) during their stay in the epilepsy monitoring unit. The performances of both methods were assessed based on the gold standard of video-EEG annotations. In total 89 adults (54 paper and 35 app users) with focal epilepsy were included in the analysis, of which 58 (33 paper and 25 app users) experienced at least one seizure and made at least one seizure diary entry. We observed a high precision of 85.7% for the app group, whereas the paper group's precision was lower due to overreporting (66.9%). Sensitivity was similar for both methods. Our findings imply that performance of seizure self-reporting is patient-dependent but is more precise for patients who are willing to use digital apps. This may be relevant for treatment decisions and future clinical trial design.


Subject(s)
Epilepsy , Mobile Applications , Seizures , Self Report , Humans , Male , Female , Adult , Middle Aged , Seizures/diagnosis , Seizures/physiopathology , Epilepsy/diagnosis , Epilepsy/physiopathology , Electroencephalography/methods , Young Adult , Aged
2.
BJOG ; 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39010306

ABSTRACT

OBJECTIVE: To compare the effectiveness of endometriosis excision alone to excision plus hysterectomy, with and without bilateral oophorectomy, for endometriosis-related symptoms. DESIGN: Multicentre prospective cohort. SETTING: Eighty-six specialist endometriosis centres. POPULATION: Women undergoing rectovaginal endometriosis surgery between 2009 and 2021. METHODS: We performed multivariable regression with random effects for patient and centre, controlling for age, BMI, smoking, laparoscopic versus open approach and type of bowel surgery performed, with sensitivity analysis for loss to follow-up. MAIN OUTCOME MEASURES: Pain scores, bowel symptoms and quality-of-life measures. RESULTS: Compared to endometriosis excision alone, women undergoing hysterectomy with conservation of ovaries had greater improvement in non-cyclical pain (MD: 1.41/10, 95% CI: 1.03-1.78, p < 0.001), dyspareunia (MD: 1.12/10, 95% CI: 0.71-1.53, p < 0.001), back pain (MD: 1.29/10, 95% CI: 0.92-1.67, p < 0.001) and quality-of-life scores (MD: 8.77/100, 95% CI: 5.79-11.75, p < 0.001) at 24 months post-operatively. Women undergoing hysterectomy with bilateral oophorectomy also had greater improvement in non-cyclical pelvic pain (MD: 2.22/10, 95% CI: 1.80-2.63, p < 0.001), dyspareunia (MD: 1.05/10, 95% CI: 0.59-1.52, p < 0.001), back pain (MD: 1.18/10, 95% CI: 0.77-1.59, p < 0.001) and quality of life (MD: 12.41/100, 95% CI: 9.07-15.74, p < 0.001) at 24 months compared to endometriosis excision alone. Compared to hysterectomy with ovarian conservation, hysterectomy with bilateral oophorectomy was associated with greater improvement in non-cyclical pelvic pain (MD: 0.81/10, 95% CI: 0.32-1.30, p = 0.001) at 24 months and quality of life (MD: 3.74/100, 95% CI: 0.56-6.92, p = 0.021) at 12 months, although this result was sensitive to loss to follow-up. CONCLUSIONS: Patients who undergo endometriosis excision plus hysterectomy experience greater improvement in pain and quality of life compared to those who have endometriosis excision alone. There are additional benefits of bilateral oophorectomy with hysterectomy, although its value is less clear due to loss of follow-up.

3.
Fertil Steril ; 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38838806

ABSTRACT

OBJECTIVE: To determine whether obstetric outcomes differ between women with endometriosis and those without, where all women undergo first-trimester screening for endometriosis. DESIGN: A prospective observational cohort study. SETTING: The Early Pregnancy Unit at University College London Hospital, United Kingdom. PATIENTS: Women with a live pregnancy progressing beyond 12 weeks' gestation and concurrent endometriosis (n = 110) or no endometriosis (n = 393). INTERVENTION: All women underwent a pelvic ultrasound examination in early pregnancy to examine for the presence of endometriosis and uterine abnormalities. MAIN OUTCOME MEASURES: The primary outcome of interest was preterm birth, defined as delivery before 37 completed weeks' gestation. Secondary outcomes included late miscarriage, antepartum hemorrhage, placental site disorders, gestational diabetes, hypertensive disorders of pregnancy, neonates small for gestational age, mode of delivery, intrapartum sepsis, postpartum hemorrhage, and admission to the neonatal unit. RESULTS: Women with a diagnosis of endometriosis did not have statistically significantly higher odds of preterm delivery (adjusted odds ratio [aOR] 1.85 [95% confidence interval {CI} 0.50-6.90]), but they did have higher odds of postpartum hemorrhage during cesarean section (aOR 3.64 [95% CI 2.07-6.35]) and admission of their newborn infant to the neonatal unit (aOR 3.24 [95% CI 1.08-9.73]). Women with persistent or recurrent deep endometriosis after surgery also had higher odds of placental site disorders (aOR 8.65 [95% CI 1.17-63.71]) and intrapartum sepsis (aOR 3.47 [95% CI 1.02-11.75]). CONCLUSION: We observed that women with endometriosis do not have higher odds of preterm delivery, irrespective of their disease subtype. However, they do have higher odds of postpartum hemorrhage during the cesarean section and newborn admission to the neonatal unit.

4.
N Engl J Med ; 390(13): 1234-1236, 2024 Apr 04.
Article in English | MEDLINE | ID: mdl-38598581

Subject(s)
COVID-19 , Humans
5.
Acta Neurochir (Wien) ; 166(1): 145, 2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38514531

ABSTRACT

PURPOSE: This study is to report some preliminary surgical considerations and outcomes after the first implantations of a new and commercially available implantable epicranial stimulation device for focal epilepsy. METHODS: We retrospectively analyzed data from clinical notes. Outcome parameters were as follows: wound healing, surgery time, and adverse events. RESULTS: Five patients were included (17-52 y/o; 3 female). Epicranial systems were uneventfully implanted under neuronavigation guidance. Some minor adverse events occurred. Wound healing in primary intention was seen in all patients. Out of these surgeries, certain concepts were developed: Skin incisions had to be significantly larger than expected. S-shaped incisions appeared to be a good choice in typical locations behind the hairline. Preoperative discussions between neurologist and neurosurgeon are mandatory in order to allow for the optimal coverage of the epileptogenic zone with the electrode geometry. CONCLUSION: In this first small series, we were able to show safe implantation of this new epicranial stimulation device. The use of neuronavigation is strongly recommended. The procedure is simple but not trivial and ideally belongs in the hands of a neurosurgeon.


Subject(s)
Drug Resistant Epilepsy , Epilepsy , Humans , Female , Epilepsy/surgery , Retrospective Studies , Drug Resistant Epilepsy/surgery , Cerebral Cortex , Electrodes, Implanted , Treatment Outcome
6.
Cyberpsychol Behav Soc Netw ; 27(6): 363-371, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38513055

ABSTRACT

Virtual reality (VR) is a potent educational tool with untapped potential in medical training. However, its integration into medical schools faces challenges such as cybersickness and hesitancy among medical students and professionals. Notably, there has been no systematic assessment of the acceptance of medical educational VR applications by both students and educators. In our single-center study, we enrolled 133 medical students and 14 medical educators. Following a practical demonstration of the established VR anatomy application, Sharecare YOU VR, participants completed a self-reporting survey based on the Technology Acceptance Model (TAM), exploring user acceptance of information technologies and focusing on perceived usefulness (PU), perceived ease of use (PEU), and attitude toward using (ATU). We also sought insights into potential future applications of VR in medical education. Our findings indicate a high level of acceptance among medical students and educators upon structured exposure to VR with significantly positive responses for all three TAM variables (PU, PEU, and ATU). Intriguingly, hands-on experience influenced acceptance. Students envisioned VR's benefits in anatomy, surgery, emergency medicine, and communication skill training with patients. Both students and educators believed that VR could enhance traditional approaches and complement the existing curriculum, anticipating improved preparedness for medical students through VR training applications. In conclusion, our results demonstrate the receptivity of both students and educators to immersive technologies, including VR, in medical education. Importantly, the data suggest that the adoption of VR in this field would be welcomed rather than resisted, potentially enhancing students' self-efficacy and enriching the medical school curriculum.


Subject(s)
Students, Medical , Virtual Reality , Humans , Students, Medical/psychology , Male , Female , Adult , Young Adult , Faculty, Medical/psychology , Education, Medical/methods
7.
Epilepsia ; 65(3): 630-640, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38135903

ABSTRACT

OBJECTIVE: Cenobamate, a novel antiseizure medication with a dual mechanism of action, has been shown in pivotal trials to significantly improve seizure control in treatment-resistant focal epilepsy. We aimed to evaluate whether these promising results could be confirmed in a real-world setting with a follow-up period of up to 12 months. METHODS: Patients from a tertiary epilepsy center who received cenobamate add-on between June 2021 and October 2023 were followed up prospectively at 3, 6, and 12 months after treatment initiation for assessment of seizure outcomes and treatment-related adverse events. RESULTS: The clinical cohort included 112 adult patients with 30% nonlesional cases and a wide spectrum of epileptogenic lesions underlying refractory focal epilepsy. We observed a significant reduction in monthly seizure frequency of all seizure types already after 3 months of treatment at a median cenobamate dose of 100 mg/day. Forty-six percent of patients were responders with a ≥50% seizure reduction, 26% had a ≥75% seizure reduction, and 9% became seizure-free. Among the 74 patients with available follow-up of 12 months, the responder rates reached 55%, 35%, and 19% for ≥50%, ≥75%, and 100% seizure reduction, respectively. After 3 months of treatment, 38% of patients reported adverse effects, mainly (84%) mild to moderate in intensity. Adjustment of comedication allowed successful management of adverse effects in 32% of patients. At a group level, there was no correlation between the cenobamate daily dose and the incidence of adverse events. SIGNIFICANCE: We found a clinically relevant response to cenobamate already at a low daily dose of 100 mg also in a patient cohort with a higher degree of drug resistance than in pivotal trials. Our prospectively collected data provide real-world evidence for high efficacy and good tolerability of the drug, although no standardized treatment protocol or comparison with a control group was applied.


Subject(s)
Carbamates , Chlorophenols , Drug Resistant Epilepsy , Drug-Related Side Effects and Adverse Reactions , Epilepsies, Partial , Tetrazoles , Adult , Humans , Anticonvulsants/therapeutic use , Drug Therapy, Combination , Epilepsies, Partial/drug therapy , Seizures/drug therapy , Drug Resistant Epilepsy/drug therapy , Drug Resistant Epilepsy/chemically induced , Treatment Outcome
8.
CNS Drugs ; 37(11): 973-980, 2023 11.
Article in English | MEDLINE | ID: mdl-37921919

ABSTRACT

BACKGROUND AND OBJECTIVES: Eslicarbazepine acetate (ESL) is a third-generation anti-seizure medication for patients with focal-onset epilepsy. There are known short-term impacts of classic enzyme-inducing drugs on bone health. For oxcarbazepine, which like ESL is a less potent inducer of cytochrome P450 (CYP450) than carbamazepine, some studies have shown that treatment is associated with increased bone metabolic parameters. The effects of ESL on bone health have not been systematically evaluated so the objective of this study was to investigate whether adverse effects of ESL on bone mineral density (BMD) could be measured after a 12-month exposure period. In addition, the effects of ESL on bone turnover were investigated using laboratory indicators of bone metabolism. METHODS: BONAPARTE was a prospective, longitudinal, observational study that enrolled patients with focal-onset epilepsy with or without secondary generalization who started treatment with ESL, either as adjunctive treatment or monotherapy, at two tertiary epilepsy centres in Germany between February 2018 and July 2020. Standardised osteodensitometry and biochemical bone metabolism parameters at the time of ESL initiation and 1 year after continuation of therapy were assessed. Comparisons between biochemical and densitometric parameters at baseline and after 12 months of treatment were performed using the paired samples t test. RESULTS: In total, 26 patients (15 male; mean age 41.4 ± 12.5 years) newly treated with ESL were evaluated. Six of these patients had osteopenia at baseline. The mean daily dose of ESL at the 12-month follow-up was 1438 ± 1406 mg. At the group level, there were no significant effects of treatment with ESL on laboratory markers or on BMD. Mean values of BMD in g/cm2 at baseline and after 12 months of ESL treatment were 1.17 (± 0.16) and 1.16 (± 0.16) in the lumbar spine, and 0.98 (± 0.15) and 0.96 (± 0.15) in the proximal femur, respectively. Intra-individually, two patients developed de novo osteopenia measured at the femoral neck associated with relevant changes in bone metabolic parameters. CONCLUSION: Neither osteodensitometry nor bone metabolism parameters showed significant group effects after 1 year of treatment with ESL. Individual fluctuations were observed, however, which may warrant monitoring for longer follow-up periods. The study was registered in the German register for clinical studies under the number DRKS00010430 with the official name BONAPARTE.


Subject(s)
Bone Diseases, Metabolic , Dibenzazepines , Epilepsies, Partial , Epilepsy , Adult , Humans , Male , Middle Aged , Anticonvulsants/adverse effects , Bone Density , Bone Diseases, Metabolic/chemically induced , Bone Diseases, Metabolic/drug therapy , Dibenzazepines/adverse effects , Epilepsies, Partial/drug therapy , Epilepsy/drug therapy , Longitudinal Studies , Prospective Studies , Treatment Outcome , Female
10.
Inn Med (Heidelb) ; 64(11): 1072-1076, 2023 Nov.
Article in German | MEDLINE | ID: mdl-37801097

ABSTRACT

Hardly any other field of application of artificial intelligence (AI) needs more ethics by design than medicine; however, if a deep integration of ethical principles succeeds there is a chance of "deep healing", for each individual and also for medicine and the healthcare system itself. Thus, AI in medicine could also become a blueprint for how AI should enter society and culture.


Subject(s)
Artificial Intelligence , Medicine , Moral Obligations , Wound Healing
11.
Epilepsia Open ; 8(4): 1616-1621, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37842739

ABSTRACT

Treatment decisions in epilepsy critically depend on information on the course of the disease, its severity and options for specific local interventions. We here report a patient with pharmaco-resistant non-lesional temporal lobe epilepsy with evidence for predominant right temporal epileptogenesis. While seizure frequency had been grossly underestimated for many years, ultralong-term monitoring with a subcutaneous EEG device revealed actual seizure frequency (66 over 11 months vs four patient-documented seizures), providing objective data on treatment efficacy and additional supportive lateralizing information that played a decisive role for the choice of surgical treatment, which had been rejected by the patient prior to this information.


Subject(s)
Epilepsy, Temporal Lobe , Epilepsy , Humans , Epilepsy, Temporal Lobe/diagnosis , Epilepsy, Temporal Lobe/surgery , Electroencephalography , Seizures , Monitoring, Physiologic
12.
Inn Med (Heidelb) ; 64(11): 1051-1057, 2023 Nov.
Article in German | MEDLINE | ID: mdl-37737496

ABSTRACT

For the integration of artificial intelligence (AI) systems into medical processes it is decisive to address both the trustworthiness of these systems and the trust that physicians and patients have in those systems. Too much trust can result in physicians uncritically relying on this technology, while too little trust may result in physicians not taking advantage of the full potential of AI-based technology in making decisions. To strike a balance between these extremes it is crucial to correctly assess the trustworthiness of a system. Only in this way is it possible to decide whether or the system can be trusted or not. This article describes these relationships for the medical context. We show why trustworthiness and trust are important in the use of AI-based systems and how individuals can come to an accurate assessment of the trustworthiness of AI-based systems.


Subject(s)
Artificial Intelligence , Physicians , Humans , Trust , Technology
13.
Curr Opin Obstet Gynecol ; 35(5): 440-445, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37548229

ABSTRACT

PURPOSE OF REVIEW: Fibroids are benign pelvic masses and constitute the most common gynaecological condition. They create a significant health and social burden to many women because of heavy menstrual bleeding and fibroid pressure symptoms. Many women will be faced with the dilemma of surgical management to improve their symptoms at some point of their reproductive age. The aim of this article is to identify current surgical management of fibroids describing the technical steps, advantages, disadvantages and risks of each method. RECENT FINDINGS: The surgical management of fibroids remains challenging, as the overall prevalence, the clinical experience and the patient awareness is increasing because of an upgrade in our sonographic and magnetic resonance diagnostic tools. Unfortunately not every patient is able to benefit from tailor-made surgery that holistically evaluates individual needs including fertility aspirations. SUMMARY: This article provides the most current synopsis of every available surgical modality for fibroid management. Large prospective multicentre cohort studies are needed to definitely determine the most suitable operation for any individual suffering with fibroids; and perhaps artificial intelligence may offer a valuable tool in the future data analysis.


Subject(s)
Leiomyoma , Menorrhagia , Uterine Neoplasms , Female , Humans , Uterine Neoplasms/surgery , Uterine Neoplasms/pathology , Prospective Studies , Artificial Intelligence , Leiomyoma/surgery , Leiomyoma/pathology
14.
Curr Opin Obstet Gynecol ; 35(5): 434-439, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37610988

ABSTRACT

PURPOSE OF REVIEW: The use of hormonally suppressive medication to reduce levels of reproductive hormones around the time of surgery is widely used in the management of endometriosis. This review summarizes the current evidence concerning the perioperative use of hormonal treatment in the management of endometriosis. RECENT FINDINGS: European Society of Human Reproduction and Embryology (ESHRE) guidanceSurgical Outcomes and Complications of Laparoscopic Hysterectomy for Endometriosis: A Multicentre Cohort StudyPre and postsurgical medical therapy for endometriosis surgery. Cochrane 2020Postoperative hormonal treatment for prevention of endometrioma recurrence after ovarian cystectomy: a systematic review and network meta-analysis. BJOG 2021. SUMMARY: The literature highlights the importance of hormonal treatment for symptom relief, reduced surgical complications and postoperative benefits, including a reduction in pain, disease recurrence and improved pregnancy rates. The treatment of endometriosis can be broadly categorized into medical, commonly using hormonal suppression medications and surgical, in which endometriosis tissue is excised or ablated. This review aims to outline current management strategies and examines the relationship between the two treatment modalities.


Subject(s)
Endometriosis , Female , Humans , Pregnancy , Endometriosis/drug therapy , Endometriosis/surgery , Hysterectomy , Ovariectomy , Pain , Postoperative Period
15.
Seizure ; 111: 78-86, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37549617

ABSTRACT

PURPOSE: To determine if growing evidence for epilepsy surgery as an early treatment option is reflected in the decrease of latencies between epilepsy onset and referral for presurgical evaluation METHODS: Retrospective analysis of latencies in 1646 patients (children and adults) from the time of epilepsy diagnosis to first presurgical workup in the period from 1999 to 2019 based on electronic patient charts at a tertiary epilepsy center. Time spans 1999-2009 and 2010-2019, prior to and following the ILAE definition of pharmacoresistance, and the role of etiological factors were assessed. RESULTS: Over the whole period, the mean latency between diagnosis and a presurgical workup was 15.3 y. There was a significant reduction in the latencies between the periods 1999-2009 (16.9 y) and 2010-2019 (13.4 y), (p < 0.0001). In a linear regression analysis, the latency decreased by 2.6 months/year from 17.4 in 1999 to 13.1 y in 2019 (p < 0.001). Subgroup analyses showed significant decreases in latency to presurgical evaluation in patients with hippocampal sclerosis from 24.4 to 19.5 y, in malformations of cortical development from 16.4 to 13.2 y, and in nonlesional patients from 18.1 to 12.8 y, in contrast to patients with MR evidence for brain tumors with similar latencies across time (10.5 vs. 9.5 y, n.s.). CONCLUSION: The reduction of the time span to a first presurgical evaluation was highly significant over time, yet moderate in its degree. Overall, the aim of early diagnostic evaluation for epilepsy surgery options after established pharmacoresistance was only achieved for a minority of patients.


Subject(s)
Brain Neoplasms , Epilepsy , Child , Adult , Humans , Retrospective Studies , Epilepsy/diagnosis , Epilepsy/surgery , Epilepsy/pathology , Treatment Outcome , Brain Neoplasms/surgery , Neurosurgical Procedures , Electroencephalography
16.
Epilepsy Behav ; 145: 109319, 2023 08.
Article in English | MEDLINE | ID: mdl-37406558

ABSTRACT

OBJECTIVE: The differentiation and assessment of anxiety in persons with epilepsy is the subject of current research. There is no consensus on which forms of anxiety are epilepsy-specific, what pathological significance they have, and how they should be conceptually systematized. The aim of this study was to detect formal landmarks that organize and further distinguish the clinical multitude of epilepsy-related anxiety, thereby establishing a basis on which an integrative assessment of epilepsy-specific fears can be developed. METHOD: Twenty-six patients with epilepsy-related fears were recruited for qualitative interviews at the Epilepsy Center of Freiburg in Germany. Prevalent types of anxiety included both periictal and interictal anxiety. Patients reported how living with epilepsy is associated with anxiety and to what extent. After an open interview, semi-structured questions were asked concerning epilepsy-specific anxiety, referring to established concepts and items. The contents of the interviews relating to anxiety were transcribed. RESULTS: The reported fears associated with epilepsy reflect the individual "pathography" of each patient. The potentially anxiety-inducing events within this pathography include the first seizure(s), especially in cases involving the amygdalae; the process of diagnostic procedures; therapy, including side effects of antiseizure medication, surgery as a therapeutic option, or a difficult physician-patient relationship; and the further course of the disease, including the fear of disease progression with brain damage, cognitive deterioration, or professional and social disintegration. The integrative assessment model derived from the pathography of the interviewed patients thus reflects the dynamics and quality of epilepsy-specific fears, especially in relation to the healthcare system, without instantly pathologizing them. It highlights that anxiety, to a variable degree, is perceived as an adequate and comprehensible emotion and might be a problem long before the diagnosis is made in the case of ictal fear. Furthermore, anxiety symptoms may (re-)emerge, consolidate, modulate, diminish, or even aggravate during the course of the disease. The integrative assessment model maps crucial events inherent to the healthcare system that may become relevant as objects of prevention, intervention, and therapy. CONCLUSION: The integrative assessment model can serve as a heuristic framework from which an integrative self-report questionnaire of epilepsy-specific anxiety might be designed. On the one hand, this would help to better understand the interrelation between epilepsy and anxiety in terms of their temporal occurrence and interdependence scientifically. On the other hand, it would allow for the enhancement of individual preventive and therapeutic measures for affected patients.


Subject(s)
Anxiety , Epilepsy , Humans , Anxiety/etiology , Anxiety Disorders , Epilepsy/complications , Epilepsy/psychology , Fear , Seizures/psychology , Qualitative Research
17.
J Infect Dis ; 228(8): 975-978, 2023 10 18.
Article in English | MEDLINE | ID: mdl-37145101
18.
JAMA Neurol ; 80(6): 588-596, 2023 06 01.
Article in English | MEDLINE | ID: mdl-37010826

ABSTRACT

Importance: For the large population of people with drug-refractory epilepsy, alternative treatment approaches are needed. Clinical trial outcomes of a novel stimulation device, which is newly available in Europe for the treatment of patients with a predominant seizure focus, are reported for the first time. Objective: To perform a pooled analysis of the results of 2 prospective, multicenter, single-arm trials, A Pilot Study to Assess the Feasibility of Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (EASEE II) and A Pilot Study to Assess the Feasibility of Patient-Controlled Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (PIMIDES I), assessing the safety and efficacy of epicranial focal cortex stimulation (FCS) with a novel implantable device (EASEE [Precisis]) as adjunctive treatment for adult patients with drug-refractory focal epilepsy. Design, Setting, and Participants: This study was a pooled analysis of 2 nonrandomized uncontrolled trials, EASEE II and PIMIDES I, which began on January 15, 2019, and January 14, 2020, respectively, and ended on July 28, 2021. EASEE II and PIMIDES I were the first in-human, prospective, single-arm trials with an 8-month evaluation period. Patients were recruited at 7 European epilepsy centers. Consecutive participants with drug-refractory focal epilepsy were enrolled. Study data were analyzed from September 29, 2021, to February 2, 2022. Interventions: After a 1-month prospective baseline period, patients were implanted with the neurostimulation device. After a 1-month postimplantation recovery period, unblinded FCS was activated using both high-frequency and direct current (DC)-like components performed via electrode arrays placed epicranially above the individual epileptic focus region. Main Outcomes and Measures: Efficacy was prospectively assessed by the responder rate in the sixth month of stimulation compared with baseline; safety and additional end points were assessed after device implantation and during the stimulation period. Results: Of the 34 adult patients enrolled at 6 German and 1 Belgian investigational site, 33 (mean [SD] age, 34.6 [13.5] years; 18 male patients [54.5%]) received the neurostimulation device implant. A total of 32 patients underwent combined high-frequency direct current-like stimulation at least until the 8-month postimplant follow-up visit. After 6 months of stimulation, 17 of 32 patients (53.1%) were responders to treatment with at least a 50% reduction in seizure frequency compared with baseline, corresponding to a significant median seizure reduction by 52% (95% CI, 0.37%-0.76%; P < .001). No device- or procedure-related serious adverse events were reported (0; 95% CI, 0%-10.58%). There were no significant alterations in cognition, mood, or overall quality of life. Conclusions and Relevance: Results of this pooled analysis of 2 nonrandomized uncontrolled trials suggest that FCS with a novel neurostimulation device was associated with an effective reduction in seizure frequency in patients with drug-refractory focal epilepsy and may offer a promising treatment option for patients with a predominant epileptic focus. Trial Registration: German Clinical Trials Register: DRKS00015918 and DRKS00017833, respectively, and jointly under PROSPERO: CRD42021266440.


Subject(s)
Drug Resistant Epilepsy , Epilepsies, Partial , Epilepsy , Adult , Humans , Male , Quality of Life , Prospective Studies , Pilot Projects , Epilepsy/drug therapy , Epilepsies, Partial/therapy , Seizures/drug therapy , Drug Resistant Epilepsy/therapy , Anticonvulsants/therapeutic use , Treatment Outcome
19.
Epilepsia Open ; 8(2): 673-677, 2023 06.
Article in English | MEDLINE | ID: mdl-36929857

ABSTRACT

Whereas high-level evidence exists on chronic neuromodulatory effects of different brain stimulation approaches in reducing seizure frequency, evidence for acute antiseizure effects of electrical brain stimulation during seizures is sparse. As part of an ongoing trial, we implanted a patient with a novel focal cortex stimulation (FCS) device with a Laplacian electrode placed over a precentral focal cortical dysplasia. The baseline seizure frequency was 125 per month, consisting of (i) focal aware sensory seizures that invariably progressed to uni- or bilateral tonic contraction and clonic jerking, and (ii) primary motor seizures. Besides an overall reduction in seizure frequency, on-demand stimulation had an immediate effect on seizures with a sensory phase, whereby 63%-86% of these seizures were terminated by ictal stimulation. These observations provide the first evidence that ictal self-triggered transcranial focal cortex stimulation can significantly interfere with the progression of seizure semiology.


Subject(s)
Deep Brain Stimulation , Seizures , Humans , Brain , Cerebral Cortex , Electric Stimulation , Seizures/therapy , Male , Adult
20.
BMC Pregnancy Childbirth ; 23(1): 76, 2023 Jan 28.
Article in English | MEDLINE | ID: mdl-36709255

ABSTRACT

BACKGROUND: This systematic review aims to explore the prevalence of the impact of the COVID-19, MERS, and SARS pandemics on the mental health of pregnant women. METHODS: All COVID-19, SARS and MERS studies that evaluated the mental health of pregnant women with/without gynaecological conditions that were reported in English between December 2000 - July 2021 were included. The search criteria were developed based upon the research question using PubMed, Science Direct, Ovid PsycINFO and EMBASE databases. A wide search criterion was used to ensure the inclusion of all pregnant women with existing gynaecological conditions. The Newcastle-Ottawa-Scale was used to assess the risk of bias for all included studies. Random effects model with restricted maximum-likelihood estimation method was applied for the meta-analysis and I-square statistic was used to evaluate heterogeneity across studies. The pooled prevalence rates of symptoms of anxiety, depression, PTSD, stress, and sleep disorders with 95% confidence interval (CI) were computed. RESULTS: This systematic review identified 217 studies which included 638,889 pregnant women or women who had just given birth. There were no studies reporting the mental health impact due to MERS and SARS. Results showed that women who were pregnant or had just given birth displayed various symptoms of poor mental health including those relating to depression (24.9%), anxiety (32.8%), stress (29.44%), Post Traumatic Stress Disorder (PTSD) (27.93%), and sleep disorders (24.38%) during the COVID-19 pandemic. DISCUSSION: It is important to note that studies included in this review used a range of outcome measures which does not allow for direct comparisons between findings. Most studies reported self-reported measure of symptoms without clinical diagnoses so conclusions can be made for symptom prevalence rather than of mental illness. The importance of managing mental health during pregnancy and after-delivery improves the quality of life and wellbeing of mothers hence developing an evidence-based approached as part of pandemic preparedness would improve mental health during challenging times. OTHER: The work presented in this manuscript was not funded by any specific grants. A study protocol was developed and published in PROSPERO (CRD42021235356) to explore several key objectives.


Subject(s)
COVID-19 , Sleep Wake Disorders , Female , Pregnancy , Humans , Mental Health , Pandemics , COVID-19/epidemiology , Prevalence , Quality of Life , Parturition , Anxiety/epidemiology , Sleep Wake Disorders/epidemiology , Depression/epidemiology
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