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A Study to Find if the Microbe Environment of the Intestines Predicts Response to the Ketogenic Diet
Rochester, MN
The purpose of this study is to see if the microbial environment of the intestines can predict the success of the ketogenic diet for children with medically unmanageable epilepsy.
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A Study Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
Rochester, MN
This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in the core study (ZX008-1501 and ZX008-1502).
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A Study to Review Magnetic Resonance Imaging in Patients with Epilepsy
Rochester, MN
The primary purpose of this study is to compare the diagnostic utility of 7T MRI versus 3T MRI in the detection of subtle epileptogenic lesions in the brain.
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A Study to Characterize the Performance of Brain Laser (LITT) Ablation for Treating Epilepsy that is Resistant to Medical Therapy
Jacksonville, FL
The purpose of this study is to characterize the use of the Monteris NeuroBlate System for the performance of brain laser interstitial thermal therapy (LITT) ablation treatment of medial temporal lobe epilepsy that is resistant to medical tharapy.
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A Study of the Effectiveness of Deep Brain Stimulation for Epilepsy in Pediatric Patients
Rochester, MN
The purpose of this study is to assess the response of pediatric epilepsy patients to deep brain stimulation.
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A Study of a New Recording Electrode to Record Brain Activity During Surgery
Rochester, MN
This research study will investigate a new recording electrode that will record brain activity during surgery. This electrode is being tested for efficacy, and may eventually replace the current electrodes used for this purpose. The goal is to record brain activity in a region of the brain that is already being removed to treat epilepsy.
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Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
Rochester, MN
The purpose of this study is to evaluate effectiveness, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an addietional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.
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Characteristics of Headache in Children with Epilepsy
Rochester, MN
Our aims of the protocol in this case series study are to review characteristics of headache (i.e. type, timing relative to seizure event, frequency, duration, laterality, quality) and the efficacy of typical therapeutic strategies.
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The Human Epilepsy Project
Rochester, MN
HEP is a five-year, prospective, observational study whose primary goal is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with newly treated focal epilepsy.
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A Study to Evaluate Biomarker Target Stimulation
Rochester, MN
The purpose of this study is to understand how electrical stimulation of the brain can modulate and suppress interictal epileptiform activity as a step on the path to developing new therapies for epilepsy.
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A Study of Systemic Markers of Inflammation and Neural Injury in Healthy Controls
Rochester, MN
The role of the immune system in epilepsy is currently unknown. We also do not know if neurons (nervous system cells) are injured in patients with epilepsy during seizures. The purpose of this study is to measure markers of immune activation and neuronal injury in your blood so that we can compare the levels of these factors in healthy individuals to the levels measured in patients with epilepsy. A specific component of this study is the collection of blood from healthy subjects at 5 different times during the same day (6 AM, 9 AM, 12 PM, 3 PM, 6 PM). ...
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A Study of 7T MRI to Find Very Small Lesions in Patients with Hard to Control Partial Epilepsy
Rochester, MN
This study will use powerful 7T MRI scanning to find very small brain lesions that cause partial epileptic seizures.These small lesions can be missed by current MRI scanners. When a neurosurgeon can find and remove the small area where the seizure starts, it is often possible to cure the epilepsy.
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A Study Using SAGE-547 for Super Resistant Status Epilepticus
No Locations
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the effectiveness and safety of SAGE-547 administered as a continuous intravenous infusion to patients in very resistant status epilepticus.
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A Study to Gather a Database of Normal and Epilepsy Brain Scans
Rochester, MN
The purpose of this study is to build a database to do comparison studies of epilepsy patients and normal controls with Magnetic Resonance Imaging(MRI) and Electroencephalogram (EEG).
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A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
Rochester, MN
The purpose of this study is to develop new approaches to improve the existing medications to relieve patients' epilepsy, and OPC-214870 is being studied for this purpose.
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Mayo MRI White-Matter-Nulled Imaging Study
Rochester, MN
The purpose of this MRI calibration study is to determine usability and optimize functionality of the MRI acquisition and post-processing techniques for white matter null imaging.
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Challenges in Medication Coverage in Pediatric Epilepsy
Rochester, MN
The purpose of this study is to (1) determine how often children with epilepsy have delays in obtaining prescribed anti-seizure medications due to cost and prior authorization process (2) determine whether delays in obtaining medications, if present, affect seizure control and (3) determine whether delays in obtaining medications lead to seizure-related complications or hospitalizations.
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A Study to Evaluate Thalamic Stimulation to Prevent Impaired Consciousness in Epilepsy
Rochester, MN
The purpose of this study is to investigate the feasibility and safety of thalamic CL stimulation in restoring consciousness in epilepsy patients.
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Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy
Rochester, MN
The main purpose of the study is to demonstrate the performance and safety of the 24/7 EEG™ SubQ system as a reliable ultra long-term recorder of epileptic electrographic seizures. First, by comparison to simultaneously recorded video-EEG in the epilepsy monitoring unit (gold standard). Second, by comparison to self-reported seizure log books throughout 12-52 weeks of outpatient EEG monitoring.
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A Study to Evaluate Brain Computer Interface (BCI) and Electrocorticography (ECoG)- based Mapping of Sensori-motor and Language Modalities Utilizing Subdural Electrodes in the Human Brain
Jacksonville, FL
The purpose of this study is to advance our understanding of the connectivity, causal role, and dynamic modulation of inter-areal communication in the human brain by recording electrocorticographic (ECoG) and stereoencephalographic (SEEG) brain signals during visual, auditory and sensory-motor tasks in patients awaiting invasive brain surgery with a particular focus on cortical networks engaged in perception of speech, language, and music.
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A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
Rochester, MN
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).
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A Study to Evaluate fMRI of Active Deep Brain Stimulation in Epilepsy
Jacksonville, FL
The purpose of this study is to to use functional imaging to study the mechanisms of anterior thalamic nucleus (ANT) Deep Brain Stimulation (DBS).
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Stiripentol in Dravet Syndrome
Rochester, MN
The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.
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A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of Antisense Oligonucleotide STK-001 in Children and Adolescents with Dravet Syndrome
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of single-ascending doses of STK-001 in patients with Dravet Syndrome.
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A Study of Mood Symptoms in Epilepsy Patients
Rochester, MN
The purpose of this study is to track neuropsychiatric symptoms in patients with epilepsy.
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A Study to assess the Safety of NRL-1 for the Treatment of People with Epilepsy
Rochester, MN
The purpose of this study is to evaluate the safety of giving repeat doses of NRL-1 when it is used to treat people who have epilepsy.
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Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients with Medically Refractory Partial Epilepsy
Jacksonville, FL; Rochester, MN
To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.
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A Study of the Use of Smartphone Videos to Aid in Evaluation of Epileptic Seizures
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to find out if home-recorded Smartphone videos can be used to accurately diagnose epilepsy in patients seeking evaluation for seizures. The idea is to compare the home-recorded video to video-EEG monitoring, which is the current gold-standard for diagnosis.
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A Study to Collect Health Related Data and Biological Samples that will Enable Researchers to Understand the Cause of Cryptogenic New-onset Refractory Status Epilepticus
Rochester, MN
The purpose of this study is to establish a collection of health related data and biological samples that will enable researchers to understand the cause of cryptogenic new-onset refractory status epilepticus (NORSE), to identify the key determinants of outcome and to determine the best management strategy.
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Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy
Rochester, MN
The purpose of this study is to track seizure occurrence, seizure probability, behavioral state, cognition, and mood using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy
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A Study to Evaluate Safety and Effectiveness of Ganaxolone to Treat Status Epilepticus
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish the effectiveness and safety of IV ganaxolone for the treatment of Status Epilepticus (SE) after failure of first-line benzodiazepines and two second-line IV antiepileptic drugs (AEDs)
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A Study to Examine the Natural History of Infants and Children with SCN1A-positive Dravet Syndrome
Rochester, MN
The purpose of this study is to characterize the phenotype of SCN1A-positive Dravet Syndrome in subjects aged 6 to 60 months, inclusive.
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A Study to Research Epilepsy in Adolescent Clinical Transitions
Rochester, MN
The primary aims of this study are to 1) evaluate the acceptability of implementing a novel transition program for adolescents with epilepsy; 2) evaluate the needs of patients and their families as they prepare for transition from pediatric to adult care; and 3) improve transition readiness and outcomes in youths with epilepsy.
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A Study to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection Using Intraoperative Brain Microdialysis
Rochester, MN
The purpose of this study is to measure the space and time characteristics of inflammatory mediator release in response to induced epileptiform activity in ASD-resistant patients.
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Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic Clonic Seizures
Jacksonville, FL
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects = 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 study.
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Patient Experiences of Neuromodulation for Epilepsy
Rochester, MN
The primary purpose of this study is to understand how epilepsy patients think about neuromodulation in relation to concepts of neuroexceptionalism and the self.
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Treating Epilepsy With Transcranial Direct Current Stimulation
Rochester, MN
The purpose of this study is determine the feasibility and efficacy of at-home Transcranial Direct Current Stimulation (tDCS) therapy for focal epilepsy.
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EEG Cap for Identification of Non-Convulsive Status Epilepticus
Jacksonville, FL
Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the ...
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Diazepam Trial in GAD65 Associated Epilepsy
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of Diazepam in the treatment of high-titer GAD65 associated epilepsy. Subjects will be screened at outpatient clinic visit appointments and identified from lists of patients previously evaluated. There will be a 4-week baseline period where patients will track their seizures. The patient will then be treated with diazepam 5 mg twice daily for 1 week and if tolerating will increase to 10 mg twice daily. Treatment will be continued on the trial for 6 months. Efficacy will be looked at after 2 months of treatment, but ...
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A Study to Evaluate MR-guided Focused Ultrasound Ablation Therapy to Treat Focal Epilepsy.
Rochester, MN
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the ExAblate transcranial system to produce multiple sonications targeted in the lesion of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.
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AMZ002 Compared to Vigabatrin
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of AMZ002, compared to vigabatrin, in the treatment of infantle spasms (IS).
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A Study of the Effect of the Ketogenic Diet on the Quality of Life of Children
Rochester, MN
The purpose of this study is to find out how the ketogenic diet may affect the quality of life of children.
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Remote Home-Based Monitoring Using Radio Signal Characterization of Seizures
Rochester, MN
The purpose of this study is to passively collect data on body movements, heart rate, breathing, and sleep physiology using radio signal analysis in subjects in their home environment to determine if analysis of the radio signal data (as recorded by the Emerald device) may be eventually used to detect/predict nocturnal seizures.
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A Study of the Prevalence of Headache Syndromes in Patients in the Epilepsy Monitoring Unit
Rochester, MN
The purpose of this study is to determine how frequently primary headache syndromes occur in a population of epilepsy patients admitted to an epilepsy monitoring unit.
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An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes
Rochester, MN
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet or Lennox-Gastaut syndromes.
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Study Evaluating the Safety and Efficacy of Fenfluramine Hydrochloride Oral Solution (ZX008)as Adjunctive Therapy in Children with Intractable Epilepsy with Myoclonic-Atonic Seizures
Rochester, MN
The purpose of this study is to document the effectiveness of ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008compared to baseline.
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A Study to Treat Patients with Dravet Syndrome Using ZX008
Rochester, MN
The purpose of this study is to provide patients with Dravet Syndrome, who do not qualify for participation in one of the ongoing ZX008 clinical trials, to receive treatment.
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An Open-label Extension Trial of the Effectiveness and Safety of CVL-865 to Treat Focal Onset Seizures.
Jacksonville, FL
The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.
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Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Rochester, MN
The primary purpose of this study is to evaluate the safety and tolerability of cenobamate in pediatric subjects 2 to ≤ 18 years of age with partial-onset (focal) seizures.
The seconday objectives of this study are to evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures, and the acceptability and palatability assessment (determined by a ...
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A Study to Investigate the Effectiveness and Safety of Cannabidiol (GWP42003-P; CBD) as an Added Treatment for the Seizures Associated with Lennox-Gastaut Syndrome in Children and Adults
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness and safety of the potential anti-seizure effects of cannabidiol (GWP42003-P) in children and adults with Lennox-Gastaut syndrome.
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A Study to Collect Data Elements Related to Pediatric Epilepsy Surgery
Rochester, MN
The primary objective of this study is to create common data elements collected at all centers participating in this collaborative allowing for direct data comparison amongst participating centers. Secondary objectives will compare how Pediatric Epilepsy Centers evaluate surgery candidates in order to inform future studies to compare and potentially standardize the process.
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IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
Rochester, MN
The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces significantly the number of epileptic seizures in cases of autoimmune epileptic seizures.
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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Rochester, MN
The purposes of this research are to assess the effect of NBI-827104, compared with placebo (no active drug), on the overnight epileptiform electroencephalogram (EEG) activity in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS), to evaluate the safety and tolerability of multiple doses of NBI-827104 in pediatric participants with EECSWS, and to evaluate the effect of NBI-827104 on sleep and on cognition in pediatric participants with EECSWS.
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Extension Study to Evaluate NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (Steamboat 2)
Rochester, MN
The primary objective of this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric subjects with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS) when administered for up to 106 weeks.
Its secondary objectives are to investigate the effect of NBI-827104 on the overnight epileptiform video-electroeItephalogram (video-EEG) activity in pediatric subjects with EECSWS, and to investigate the long-term effect of NBI-827104 on the symptoms of EECSWS, including sleep and cognition, in pediatric subjects.
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Prophylactic Benzodiazepine versus Reinstitution of Maintenance Antiseizure Drugs following Ictal SPECT
Jacksonville, FL
The primary aim of this study is to compare the pre- and post-single photon emission computed tomography (SPECT) seizure frequency following an IV benzodiazepine protocol versus reinstitution of maintenance antiseizure drugs (ASDS).
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Human Brain Mapping to Understand Mechanisms of Learning, Memory, and Cognition
Jacksonville, FL
The mechanisms behind how we experience the world, form memories, and make future decisions is poorly understood. We perform an observational study of rare epilepsy patients implanted with electrocorticrographic (ECoG) and stereoencephalographic (sEEG) devices in our epilepsy monitor unit to record brain signals during cognitive and memory tasks. The neural signals recorded during these computerized tasks will be invaluable for not only to discover the mysteries of our cognition, but to also advance the next generation of future diagnostic or therapeutic strategies in countless neurological diseases that affect human cognition.
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Study to Develop a Minimally-Invasive Seizure Gauge
Rochester, MN
The purpose of this study is to develop and validate all components of a minimally-invasive seizure detection and forecasting system.
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Epilepsy Genetics Initiative (EGI)
Rochester, MN
The purpose of this study is to identify genetic causes for epilepsy (sometimes referred to as seizure disorders) and associated co-morbidities such as developmental delay (DD), intellectual disability (ID), and other neurological or neurodevelopmental disorders. We are collecting genetic and clinical information from individuals who have undergone exome/genome sequencing as part of their regular medical care or as part of a research study.
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Rochester, MN
This is a single patient IND using Ampyra. The purpose of using Ampyra in this patient with epileptic encephalopathy is to control her epileptic seizures and prolong seizure free intervals.
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Is physical exercise associated with significant changes in the frequency or burden of spikes on EEG in children with epilepsy?
Rochester, MN
This study hypothesises that physical exercise in children with epilepsy will be associated with a significant reduction in interictal spikes and a significant reduction in spike burden.
This study aims to determine if vigorous physical exercise results in significant increases or reductions in spike frequency in children on continuous video EEG monitoring.
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy, with an Open-Label Extension
Jacksonville, FL
The purpose of this study is to evaluate the clinical effectiveness, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).
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A Study of Multicenter Outcomes in Pediatric Status Epilepticus
Rochester, MN
The purpose of this study is to develop a prospective status epilepticus registry among twelve tertiary care pediatric hospitals in the United States focused on standardizing status epilepticus outcome assessments.
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RNS® System RESPONSE Study
Rochester, MN
The purpose of this study is to demonstrate that the RNS® system is safe and effective as an adjunctive therapy in individuals age 12 through 17 with medically refractory partial onset epilepsy.
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A Study to Evaluate a Personal Assistant Device and Accessory Technology for Epilepsy (Enrolling by Invitation Only)
Rochester, MN
The purpose of this study is to search for necessary changes in programming or assessment structure in order to reliably capture behavioral assessments from patients during their stay in the epilepsy monitoring unit. Behavioral assessments will be collected during period of time without seizure activity, during seizure activity, and immediately after a seizure event.
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A Study to Assess Cognition and Quality of Life in Children and Adolescents with Dravet Syndrome
Rochester, MN
The purpose of this study is to evaluate the course of neurodevelopmental status, adaptive status, quality of life, seizure frequency, and sleep in patients with Dravet syndrome (DS) over the timespan of two years.
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Seizure Detection and Warning System for Epilepsy Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.
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Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Jacksonville, FL
This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with ...
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Usage of EpiFinder Clinical Decision Support in the Assessment of Epilepsy Cases at Mayo Clinic Hospital in AZ
Scottsdale/Phoenix, AZ
Clinical decision support in neurology will be using the EpiFinder tool during the assessment of patients who are being evaluated for possible epileptic seizures and syndromes. A formal knowledge representation has been created that incorporates existing accepted classifications and peer-reviewed papers in the domain from the International League Against Epilepsy. A heuristic algorithm has been developed that uses the knowledge representation in an algorithm that attempts to guide the assessment and provide a differential diagnosis of specific epilepsy syndromes encountered at Mayo Clinic Hospital’s Epilepsy Monitoring Unit in Arizona. The aim is to improve the knowledge representation, term usage, assessment process, and ...
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Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.
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Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE
Rochester, MN
The purpose of this study is to evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks. Also, to investigate the effect of NBI-921352 on long-term seizure control.
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A Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients with Rare Epilepsy
Rochester, MN
The primary purpose of this study is to investigate the long-term safety and tolerability of TAK-935/OV935 as an adjunctive therapy in patients with epileptic seizures.
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Development of a Practical, Minimally Invasive Seizure Gauge
Rochester, MN
The purpose of this study is to search for reproducible changes in a wide range of physiological signals, including photoplethysmography, accelerometry, heart rate, muscle tone and activity and EEG preceding and at the onset of seizures in patients with epilepsy.
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A Study to Evaluate Radio Signal Characterization of Seizures
Rochester, MN
The purposes of this study are to passively collect data on body movements, heart rate, breathing, and sleep physiology using radio signal analysis in subjects who are being monitored in the Mayo Clinic Epilepsy Monitoring Unit for clinical purposes, and to determine if analysis of the radio signal data (as recorded by the Emerald device) may be eventually used to detect/predict nocturnal seizures.
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A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)
Rochester, MN
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations.
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A Study of the Thalamus Using Deep Electrode EEG to Better Understand its Participation in the Beginning or Spreading of Seizures
Rochester, MN
The purpose of this study is to assess the thalamus area of the brain using stereotactic electroencephalography (an EEG with deep electrode placement inside the brain) to better understand its role in the starting and spreading of epileptic seizure activity.
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RNS® System NAUTILUS Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate that the RNS® System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.
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Genetic Markers of Cardiovascular Disease in Epilepsy
Rochester, MN
Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in ...
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An Extension Study to Assess the Safety of the Use of Cannabidiol in Children and Young Adults with Dravet or Lennox-Gastaut Syndromes
Scottsdale/Phoenix, AZ
The purpose of this extension study is to investigate the safety of using cannabidiol in children and young adults with Dravet or Lennox-Gastaut syndromes that are not well controlled.
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A Study to Test the Effectiveness and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects with Drug-resistant Epilepsy
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered simultaneously with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in adult subjects with drug-resistant epilepsy.
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Clinical Utility of the SPEAC® System: A Case Series
Jacksonville, FL
The purpose of this study is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures.
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A Study of Lacosamide to Treat Neonatal Seizures
Rochester, MN
The purpose of this study is to evaluate the effectiveness of Lacosamide (LCM) vs. an Active Comparator chosen based on Standard-of-Care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
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A Study to Identify Clinical Characteristics and Biomarkers of Disease Outcome, Progression, and Treatment Response in Participants with Treatment-resistant Focal Epilepsy
Rochester, MN
The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with treatment-resistant focal epilepsy.
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A Study to Evaluate a New Device for Increasing Accuracy and Efficiency of Image-Guided Stereo EEG Procedures
Rochester, MN
The purpose of this study is to evaluate the custom made Stealth Arc Delivery device versus a commercially available device to improve the precision, efficiency and workflow of implanting Stereo electroencephalography (sEEG) electrodes into patients who have medically unmanageable epilepsy. Successful sEEG monitoring can identify areas of the brain where epileptic seizures originate for later surgical removal.
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An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray in Adolescents and Adults With Cluster Seizures
Scottsdale/Phoenix, AZ
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
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A Study to Evaluate Patients with Dravet Syndrome Who Previously Participated in Studies of STK-001
Rochester, MN
The purpose of this study is to gather additional information on the long-term safety, tolerability, and impact on seizure frequency and duration of repeated doses of STK-001 administered every 4 months by intrathecal (IT) injection.
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Multiscale EEG Dynamics
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose if this study to combine state of the art cerebral signal processing techniques and localization methods with intracranial electrode recordings to investigate the interaction of local hippocampal and neocortical networks with distributed brain activity.
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Functional Brain Mapping by Means of Communication Practices
Rochester, MN
The purpose of this study is to establish a prospective repository of detailed patient-specific information regarding the structure and function of human brain tissue impacted by disease and therapeutic interventions, detailing the neurologic and cognitive performance during the course of disease management.
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Study Evaluating the Safety and Efficacy of Fenfluramine Hydrochloride Oral Solution as Adjunctive Therapy in Children with Doose Syndrome
Rochester, MN
The purpose of this study is to document the effectiveness of ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008 compared with baseline.
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A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Jacksonville, FL
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
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Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Rochester, MN
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
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A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
Rochester, MN
The purpose of this study is to evaluate the long-term safety of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.
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High Frequency Oscillations in Neurologic Disease
Rochester, MN
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ...
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A Study to Determine the Changes to Visual Fields and Neuropsychological Assessments after Laser Ablation for Epilepsy
No Locations
The purpose of this study is to determine the changes to visual fields and to neuropsychological assessments after laser ablation procedures for temporal lobe epilepsy.
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Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
Rochester, MN
The purpose of this trial is to assess the safety and effectiveness of Ganaxolone (GNX) compared to placebo as adjunctive therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in children and adults as assessed by the change from baselinea in the frequency of countable major motor and focal seizures (primary endpoint seizuresb) during the double-blind phase.
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A Study to Test the Effectiveness and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Jacksonville, FL
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
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Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies (PACIFIC)
Rochester, MN
The primary objective of this study is to investigate the safety, tolerability, and effectiveness of multiple doses of LP352 in adult subjects with developmental and epileptic encephalopathies.
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A Study to Assess Peripherally Circulating Plasma Proteins and Clinical Risks to Differentiate Epileptic Seizure from Psychogenic Nonepileptic Seizure
Rochester, MN
The purpose of this study is to confirm the results of a University of Pennsylvania pilot study indicating that the EvoScoreDX algorithm can differentiate patients suffering from psychogenic nonepileptic seizures (PNES) and epileptic seizures (ES) using identified proteins, demographics, and clinical data.
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Driving Safety in People with Psychogenic, Non-epileptic Seizures
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the rate of motor vehicle collisions (MVCs) due to spells in patients diagnosed with psychogenic, non-epilepic seizures (PNES) and compare to those diagnosed with epilepsy and to the general population.
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Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of Perampanel on seizure frequency in adult patients with brain-tumor with and without seizures associated with glioma.
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Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
Rochester, MN
The primary aim of Part A of the study to assess the effectiveness and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures. Part B of this study will be conducted to evaluate the long-term safety and tolerability of GWP42003-P in participants with EMAS.
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Parental and child perceptions of anxiety and depression in children with epilepsy
Rochester, MN
This study aims to assess the level of anxiety and depression in children with epilepsy and compare to the level of anxiety and depression perceived by family by using validated, standardized measures as both comorbid conditions can significantly impact both quality of life and disease course.
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Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression
Rochester, MN
The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via electroencephalographic, cognitive, and psychosocial measures.
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A Study of Neurophysiological and Inflammatory Biomarkers of Seizures and Brain Injury in Children
Rochester, MN
The purpose of this study is to connect brain inflammation measured by biomarkers, with data from advanced EEG technology, and clinical outcomes to provide new predictive information about seizure activity in children with critical brain injuries and epilepsy.
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Neural Circulatory Control and SUDEP Risk.
Rochester, MN
The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.
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A Study to Evaluate Feasibility of Microburst Vagus Nerve Stimulator (VNS) Therapy
Jacksonville, FL
The purpose of this study is to evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
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Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
Rochester, MN
The objectives of this study are to assess the effectiveness of NBI-921352 as adjunctive therapy on the frequency of countable motor seizures (defined as generalized tonic-clonic seizure [GTCS], tonic, atonic or focal onset seizures [FOS] with noticeable motor component), to evaluate the effectiveness of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change scales and the Clinical and Parent/Caregiver Global Impression of Severity scales, to explore the effect of NBI-921352 on symptoms and seizure activity, physical activity, quality of life, as well as seizure freedom. to characterize the pharmacokinetics (PK) of NBI-921352 and determine the effect of NBI-921352 on plasma levels of concomitant antiseizure ...
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MRI Techniques to Treat Seizure Disorders
Rochester, MN
This study is designed to use new MRI techniques to better understand and treat seizure disorders
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A Study to Evaluate Newly-diagnosed Idiopathic Generalized Epilepsy
Rochester, MN
The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with idiopathic generalized epilepsy (IGE).
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Human Blood and Tissues Repository for Neuroscience Research
Jacksonville, FL
The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).
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A Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer’s Disease
Jacksonville, FL
The purpose of this study is to characterize and study the relationship of the clinical risk factors and predictors of seizures and epilepsy in patients with Early Onset Alzheimer's Disease (EOAD) using a 48-hour CAA-EEG.
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A Study of Imaging and Systemic Markers in Patients with Epilepsy
Rochester, MN
The purpose of this study is to investigate if blood and/or MRI markers of inflammation and immune system activation may show changes in relation to when you have a seizure, and to noninvasively detect seizure related structural and functional alterations in acute seizure by MRI.
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Study of the Incidence of Electrographic Status Epilepticus and Seizures of PICU Patients at National Children’s Hospital in Hanoi, Vietnam.
Rochester, MN
The purpose of the study is:
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To determine the incidence of subclinical electrographic seizures and electrographic status epilepticus in children admitted to the PICU for head trauma, traumatic brain injury (TBI), and/or child abuse at National Children’s Hospital in Hanoi, Vietnam.
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To determine whether a correlation exists between length of stay, morbidity, and mortality with incidence of subclinical SE and seizures.
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A Biorepository for the Center for Multiple Sclerosis and Autoimmune Neurology
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), urine, stool, DNA and tissue specimens collected from patients who have central nervous system (CNS) inflammatory diseases.