9 Clinical Trials for Various Conditions
The purpose of this research study is to better understand what causes Sudden Unexpected Death in Epilepsy (SUDEP). This study will enroll subjects from the University of Iowa Hospitals and Clinics (UIHC) Epilepsy Monitoring Unit (EMU) and Epilepsy Clinics. The investigators will analyze the effects of seizures on breathing, on the cardiovascular system, and on arousal. The investigators are studying these effects because some cases of SUDEP might be due, in part, to an inability to wake up or sense elevated carbon dioxide (CO2) levels when breathing is impaired. Subjects will be followed for ten years after enrollment to monitor their health.
Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important risk and provide appropriate supportive follow-up resources. Moreover, existing evidence suggests that children with poorly controlled GTCS have a strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure control. Clinicians caring for these patients have multiple issues to address in the typical visit. The investigators propose to use information technology to help providers assure that addressing SUDEP is incorporated into their routine care. The investigators have developed the Child Health Improvement through Computer Automation system (CHICA), a computer based clinical decision support system for pediatric care. CHICA captures patient reported data in the waiting room and prioritizes clinical advice to the physician through the electronic health record (EHR). CHICA is used in five primary care clinics in the Eskenazi health system where it supports general pediatric care. The goal of this project is to test the effectiveness of a SUDEP module in this setting where CHICA is already in use - with a future goal of developing a full suite of CHICA modules for child neurologists.
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.
The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are: * Can Korus accurately detect body position in bed (left, right, supine, prone) * Can Korus reposition the subject from a prone to recovery (sideways) position? Participants will be asked to lie down on Korus and turn into various positions; when the prone position is detected, they will be repositioned.
The purpose of this study is to precisely delineate human brain networks that modulate respiration and identify specific brain areas and stimulation techniques that can be used to prevent seizure-induced breathing failure.
The main purpose of this study is to develop a North American registry for SUDEP cases; requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to contact the study team. The family members who decide to participate in the study will be asked to complete a brief telephone interview about their loved one's epilepsy and seizure history and the circumstances of his or her death. If the death has occurred within the past 24 hours, and the family is willing to consider donating tissue to the study, the subject will be transferred to the Autism Tissue Program, and the remainder of the phone interview will be conducted at a later time. In addition to the phone interview, the family will be asked to provide access to the deceased's medical records. Any costs involved in obtaining medical records will be covered by the study, and all medical information will remain completely confidential.
Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients with epilepsy. It ranks second only to stroke among neurological diseases in years of potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal respiratory dysfunction likely plays an important role in many cases. Literature supports a critical role for the serotonergic system in central control of ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state. In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators hypothesize that a subset of drug resistant epilepsy patients who have impaired central chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.
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 patients with epilepsy.
The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU). The investigators hypothesize that providing oxygen prior to seizures will help eliminate the drops in changes seen during seizures, such as the drop in oxygen saturation and increase in carbon dioxide levels. Research will be done on patients that are admitted to the EMU specifically to have seizures occur and to be recorded on video electroencephalography (vEEG), and the only research intervention will be the use of oxygen prior to some of the seizures. The importance of this research relates to the phenomenon of sudden unexplained death in epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found dead by their families in the morning, without a clear cause for death. The risk of SUDEP is as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to decrease significantly in 25-50% of patients during or shortly after a seizure while being monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger a cascade of events from which the body may not be able to recover, leading to SUDEP. In animal models, providing oxygen prior to seizures occurring has been shown to eliminate oxygen desaturation, but more importantly eliminate mortality in animals prone to death due to seizures. Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it reduces the risk of oxygen desaturation during the apneic period of the procedure. On room air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs from which transfer to the bloodstream can continue despite the lack of ventilation. The apneic episode during seizures should benefit from the same principle. The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better characterize seizures, to identify the main seizure focus. In addition to standard EEG with electrodes on the scalp, some patients require invasive localization of the epileptic focus by surgically placing electrodes within the skull (often referred to as GRID patients) on or within the brain, with the goal of being able to resect the area that is causing seizures. To identify where seizure originate electrically, it requires that seizures occur during the vEEG procedure. To provoke seizures, medications are typically lowered, and both partial seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators also have the capability for both for clinical usage. Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs following seizures as part of the post-ictal nursing care, though there is no outcome data to support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of oxygen desaturations clinically, as seen in animal models, and this is the goal of this research project.