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218 result(s) for "Masuda, Yosuke"
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Endovascular EEG device prospective multicenter single-arm clinical trial to confirm efficacy and safety performance on patients with Intractable Epilepsy: The EPSILON IE trial protocol
Epilepsy affects approximately 70 million people globally, with around 20-30% of these individuals experiencing drug-resistant epilepsy in which seizures remain uncontrolled despite prolonged treatment with anti-seizure medications (ASMs). Such refractory epilepsy significantly impairs quality of life, often necessitating surgical resection of the epileptic focus when ASMs fail. Accurate localization of the epileptic focus is crucial for successful surgery and typically requires invasive intracranial monitoring through subdural electrodes (SDE) or stereotactic electroencephalography (SEEG). Despite their effectiveness, the invasiveness of these methods poses significant risks. In response to these challenges, the EP-01 device has been developed to measure intracranial electroencephalogram (EEG) via the cerebral veins, offering a less invasive alternative. The Endovascular EEG Device Prospective Multicenter Single-arm clinical trial to confirm efficacy and safety performance on patients with Intractable Epilepsy (EPSILON IE) trial aims to evaluate the efficacy and safety of EP-01 in diagnosing the lateralization of epileptic foci in patients with focal epilepsy. The hypothesis is that EP-01, when equipped with multiple endovascular EEG electrodes, can accurately diagnose lateralization, reducing the need for more invasive procedures like SDE and SEEG. This multicenter, prospective, single-arm validation clinical trial is set to take place from March 2024 to August 2025, with follow-up extending to August 2026. The study will enroll 37 patients with refractory focal epilepsy across several Japanese medical institutions. Eligibility criteria include age 15-70 years and a vascular anatomy that allows the EP-01 to be guided into cerebral veins close to the epileptic focus. The EP-01 device will be inserted via the jugular veins, with electrodes positioned in target cerebral veins to record intracranial EEG data. The primary endpoint is the percentage agreement in lateralization diagnosis between EP-01 and conventional intracranial electrodes. Secondary endpoints include the diagnostic performance of EP-01, safety assessments, and seizure outcomes one year after resection surgery. Participants will undergo a screening period of 30 days, followed by the clinical trial period of up to two weeks, during which EP-01 will be inserted and monitored. A post-observation period of one week will follow device removal to assess potential adverse events. Data collection will involve EEG recordings, imaging studies, and safety evaluations, with results analyzed to determine the efficacy and safety of the device compared to traditional methods. This trial aims to provide critical data on the potential for EP-01 to serve as a less-invasive, effective alternative for diagnosing epileptic focus lateralization, potentially reducing the need for traditional invasive monitoring methods.
Endovascular Electroencephalogram Records Simultaneous Subdural Electrode-Detectable, Scalp Electrode-Undetectable Interictal Epileptiform Discharges
Introduction: We hypothesized that an endovascular electroencephalogram (eEEG) can detect subdural electrode (SDE)-detectable, scalp EEG-undetectable epileptiform discharges. The purpose of this study is, therefore, to measure SDE-detectable, scalp EEG-undetectable epileptiform discharges by an eEEG on a pig. Methods: A pig under general anesthesia was utilized to measure an artificially generated epileptic field by an eEEG that was able to be detected by an SDE, but not a scalp EEG as a primary outcome. We also compared the phase lag of each epileptiform discharge that was detected by the eEEG and SDE as a secondary outcome. Results: The eEEG electrode detected 113 (97%) epileptiform discharges (97% sensitivity). Epileptiform discharges that were localized within the three contacts (contacts two, three and four), but not spread to other parts, were detected by the eEEG with a 92% sensitivity. The latency between peaks of the eEEG and right SDE earliest epileptiform discharge ranged from 0 to 48 ms (mean, 13.3 ms; median, 11 ms; standard deviation, 9.0 ms). Conclusion: In a pig, an eEEG could detect epileptiform discharges that an SDE could detect, but that a scalp EEG could not.
Levetiracetam Versus Levetiracetam Plus Sodium Channel Blockers for Postoperative Epileptic Seizure Prevention in Brain Tumor Patients
Background Brain tumor patients tend to develop postoperative epileptic seizures, which can lead to an unfavorable outcome. Although the incidence of postoperative epileptic seizures and adverse events are improved with the advent of levetiracetam (LEV), postoperative epilepsy occurs at a frequency of 4.6% or higher. In brain tumor patients, the addition of sodium channel blockers (SCBs) to LEV significantly reduces seizures, though confirmed in a non-postoperative study. Thus, the combination of SCBs with LEV might be promising. Objective In this prospective randomized controlled trial we investigated the safety, evaluated by adverse events during one and two weeks after surgery, and the efficacy, evaluated by the incidence of early epilepsy, including non-convulsive status epilepticus (NCSE), of using LEV alone or SCBs added to LEV in patients who underwent craniotomy or biopsy for brain tumors or brain mass lesions. Methods Patients with brain tumors or brain mass lesions undergoing surgical interventions, excluding endoscopic endonasal surgery (EES), with a diagnosis of epilepsy were eligible for this study. Patients are randomized into either Group A or B (B1 or B2) after the informed consents are taken; LEV alone in Group A patients, while LEV and SCBs in Group B patients (GroupB1, intravenous fosphenytoin plus oral lacosamide (LCM) and GroupB2, intravenous LCM plus oral LCM) were administered postoperatively. Fifty-three patients were enrolled during the first two and a half years of the study and four of them were excluded, resulting in the accumulation of 49 patients' data. Results Postoperative epileptic seizures occurred only in three out of 49 patients during the first week (6.1%) and in seven patients within two weeks after surgery (14.3%, including the three patients during the first week). In Group A, epileptic seizures occurred in two out of 26 patients during the first week (7.7%) and in five patients within two weeks (19.2%) after surgery. In Group B, epileptic seizures occurred in one out of 23 patients during the first week (4.3%) and in two patients during the first two weeks (8.7%). Low complication grade of epileptic seizures was observed in Group B rather than in Group A, however, without significant difference (p=0.256). There was no difference in the frequency of adverse effects in each group. Conclusion Although not statistically significant, the incidence of epileptic seizures within one week after surgery was lesser in LEV+SCBs groups than in LEV alone. No hepatic damage or renal function worsening occurred with the addition of LCM, suggesting the safety of LEV+SCBs therapy.
Short duration of focal onset awareness and impaired awareness seizure are characteristic features of epilepsy in elderly patients
Diagnosing epilepsy in the elderly population can be difficult due to mimicking symptoms. Furthermore, epileptic symptoms can also be masked by various symptoms. We hypothesized that elderly patients with epilepsy exhibit specific clinical features among the various symptoms. From 2009 to 2017, 177 patients who were older than 65 years were referred to our epilepsy center. Out of this group, the onset of symptoms occurred after reaching the age of 50 years in 152 of the patients, who were additionally being treated at our clinic. We divided their symptoms in accordance with their consciousness levels, which were defined as follows: full wakefulness level I, impaired awareness level II, and loss of consciousness level III. We also classified the duration of the symptoms as <10 seconds, ≥10 seconds but <1 minute, ≥1 minute but <5 minutes, ≥5 minutes but <10 minutes, ≥10 minutes but <1 hour, and ≥1 hour. Among the 152 patients analyzed (mean age 72.9 years, standard deviation 6.71, range 65-92), 84 patients had epilepsy (epilepsy group) while 68 did not exhibit epilepsy (nonepilepsy group). For the consciousness levels, there were more level I patients in the nonepilepsy vs epilepsy group ( <0.028), with symptom duration lasting <1 minute (sensitivity 0.857, specificity 1) in the epilepsy group. In contrast, there were more level II patients in the epilepsy vs the nonepilepsy group ( =0.015), with the duration of symptoms lasting <1 minute (sensitivity 0.8125, specificity 0.930) in the epilepsy group. For the level III consciousness, convulsions were more commonly seen in the epilepsy group ( =0.044). Symptoms that last <1 minute with awareness and impaired awareness might be epileptic in the elderly population.
A Case of Anorexia Nervosa with Focal Cortical Dysplasia
Anorexia nervosa (AN) is a fatal condition associated with extreme underweight and undernutrition. It is more common in young females, with a female-to-male ratio of 10 : 1. Focal cortical dysplasia (FCD) is characterized by dysplasia of the cerebral cortex and is a common cause of pharmacoresistant epilepsy. However, FCD associated with AN has never been reported. We report the first case of AN in a 12-year-old male diagnosed with FCD-type 2 on head magnetic resonance imaging (MRI). He became concerned about lower abdominal distention and began reducing his food intake. He was admitted to our hospital after weight loss of 10 kg in a 1 year. Head MRI showed a localized high-signal area from the cortex to the white matter of the fusiform gyrus near the left hippocampus, with no associated decreased blood flow or electroencephalography (EEG) abnormalities. These findings were characteristic of FCD type II. In males with AN, the search for underlying disease is particularly important. The pathophysiology of the association between AN and FCD is unclear. However, both conditions are reportedly associated with autism spectrum disorder. Further cases are needed to clarify whether FCD is associated with eating disorders.
Movable intraoperative magnetic resonance imaging incorporating a seismic system
•We installed ceiling-mounted, movable intraoperative MRI with seismic system.•This arrangement is the first in the world.•Ninety-one patients underwent neurosurgical intervention using this system.•During study period, we experienced 169 seismic events.•Using this system, we have no accidental events and image quality was excellent. A high-field ceiling-mounted and movable intraoperative MR imaging (iMRI) can minimize additional risks for MRI and enhance safety by not moving the patient. In this system, hanging the heavy magnet from the ceiling requires structural stability; this stability was confirmed in earlier studies, but not proved during a seismic event. We have installed a 1.5T movable iMRI system with an incorporated seismic system in our hospital in Japan, a seismic event-prone region. This arrangement is the first in the world, to our knowledge. The objective of this study was to describe the mechanism of this seismic system and the first clinical experience using this system. The seismic system consists of a stabilizer pad that is mounted directly under the magnet, in addition to the structural stability. The seismic system was tested with using a shaker table testing at a test laboratory. Ninety-one patients underwent neurosurgical intervention using this iMRI and seismic system at our hospital. In all patients, intra-, pre, and/or postoperative MR images were successfully obtained, and image quality was excellent. The workflow of moving the magnet and scanning were smooth and unproblematic. We had 169 seismic events in our city during this time period, but had no incidental or accidental events related to the seismic events. With the use of the seismic system, a ceiling-mounted, movable iMRI system can be more safely used. This seismic system may contribute to the spread of movable iMRI systems in countries where seismic events occur.
Dual-port technique in navigation-guided endoscopic resection for intraparenchymal brain tumor
In navigation-guided endoscopic surgery performed via a single port, the interference of surgical instruments often disturbs the resection and hemostasis. With regard to this, we designed a dual-port technique for navigation-guided endoscopic surgery in a 62-year-old man, with intraparenchymal anaplastic astrocytoma. Two transparent sheaths with Nelaton tubes were inserted in the front of the target lesion via an infinity-shaped burr hole, under the control of the navigation system. The lesion was removed partially using a rigid endoscope and several surgical tools through the bilateral ports. Using the new method, it was convenient to perform hemostasis with bipolar coagulation and aspiration, without any interference from the surgical instruments during the surgery. The offered dual-port technique may be included in surgery planning for elderly patients or patients in particular conditions, with intraparenchymal brain tumors.
Detection of interictal epileptiform discharges using multiple bilateral insertions of a newly developed microcatheter-compatible endovascular electroencephalogram electrode: A clinical feasibility trial
To assess the feasibility, technical performance, and safety of a novel endovascular electroencephalogram (eEEG) electrode, EP-01, designed for minimally invasive seizure localization in patients with drug-resistant epilepsy. This single-center, prospective, exploratory trial enrolled five patients with drug-resistant epilepsy undergoing the Wada test. The EP-01 electrode, featuring a platinum monopolar tip, was inserted into the venous sinuses using a microcatheter, and simultaneous recording of eEEG and scalp electroencephalography (EEG) signals was conducted. The primary outcome was the feasibility of eEEG signal acquisition, whereas the secondary outcomes included a signal sensitivity comparison between scalp and eEEG recordings, technical success assessment, and safety evaluation. Successful eEEG recording was achieved in all five patients (mean age 34.2 years, 2 women) experiencing focal impaired awareness seizures. The EP-01 electrode successfully captured EEG signals, detecting 158 interictal epileptiform discharges (IEDs). eEEG demonstrated significantly higher amplitudes (median: 130.4 μV) compared with scalp EEG (median: 0 μV), with 57.0% of IEDs undetectable by scalp EEG (p < 0.001). EEG changes during eye opening/closing were consistently recorded by eEEG. The technical success rate was 100%, with an average of 4.5 eEEG electrodes placed per patient. The median displacement of electrode tips during neck rotation was 3.45 mm; hemorrhagic or thrombotic complications were absent; and all devices were safely removed. In this short-term study, the EP-01 eEEG device demonstrated high feasibility and safety for minimally invasive EEG acquisition in patients with epilepsy. To the best of our knowledge, this study provides the first evidence of IED detection in multiple patients using an eEEG system tailored for epilepsy monitoring, underscoring EP-01's potential for localizing seizure foci. Moreover, the capability to place multiple electrodes improves its utility in comprehensive epileptogenic mapping. Given the limited recording duration, long-term studies are necessary to validate EP-01's clinical efficacy and safety. This study tested EP-01, a new device that records brain activity from inside the blood vessels, unlike traditional scalp EEG. In five people with epilepsy, the device safely captured stronger seizure-related signals than the traditional EEG. Moreover, the device could be placed and removed without complications. This less invasive method may help doctors more accurately find where seizures begin in the brain.
Mixed Germ Cell Tumor with Extensive Yolk Sac Tumor Elements in the Frontal Lobe of an Adult
Intracranial nongerminomatous germ cell tumors (NGGCTs) in unusual locations are extremely rare. Here, we report a case of a yolk sac tumor in the frontal lobe in a middle-aged patient. A 42-year-old man was admitted to our hospital for headache and nausea. Magnetic resonance imaging (MRI) showed an enhanced mass lesion with a marked cyst component. The serum alpha-fetoprotein (αFP) level was extremely high. Histological examination of specimens after subtotal removal revealed a primary mixed germ cell tumor with extensive yolk sac tumor elements, often referred to as an intracranial “yolk sac tumor.” The preoperative diagnosis of NGGCTs in unusual age and locations is extremely difficult. Clinicians should consider the possibility of NGGCTs, including yolk sac tumors, when intracranial tumors with unusual MRI findings are encountered.
Potential use of prostate specific membrane antigen (PSMA) for detecting the tumor neovasculature of brain tumors by PET imaging with 89Zr-Df-IAB2M anti-PSMA minibody
Tumor angiogenesis has attracted increasing attention because of its potential as a valuable marker in the differential diagnosis of brain tumors as well as a novel therapeutic target. Prostate-specific membrane antigen (PSMA) is expressed by the neovasculature endothelium of some tumors, with little to no expression by the tumor cells or normal vasculature endothelium. The aim of this study was to investigate the potential of PSMA for the evaluation of the tumor neovasculature of various brain tumors and the possibility of detecting PSMA expression in brain tumors using PET imaging with 89Zr-Df-IAB2M (anti-PSMA minibody). Eighty-three tissue specimens including gliomas, metastatic brain tumors, primary central nervous system lymphomas (PCNSL), or radiation necroses were analyzed by immunohistochemical staining with PSMA antibody. 89Zr-Df-IAB2M PET scans were performed in three patients with recurrent high-grade gliomas or metastatic brain tumor. PSMA was highly expressed in the vascular endothelium of high-grade glioma and metastatic brain tumor, whereas PSMA was poorly expressed in the vascular endothelium of PCNSL and radiation necrosis. PSMA expression in high-grade gliomas and a metastatic brain tumor was clearly visualized by PET imaging with 89Zr-Df-IAB2M. Furthermore, a trend toward a positive correlation between the degree of 89Zr-Df-IAB2M uptake and PSMA expression levels in tumor specimens was observed. PET imaging of PSMA using 89Zr-Df-IAB2M may have potential value in the differential diagnosis of high-grade glioma from PCNSL or radiation necrosis as well as in the prediction of treatment efficacy and assessment of treatment response to bevacizumab therapy for high-grade glioma.