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192 active trials for Epilepsy

Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

This is a pilot research study where language and working memory tasks will be used to study brain activities from children with epilepsy. Specifically for language assessment, a well-known MEG language protocol will be used and novel signal processing techniques will be applied. A widely utilized paradigm will be used to study memory function and adapt signal-processing techniques from previous literature for the processing and analysis of MEG signals collected during memory task. No treatment/intervention will be performed or evaluated in this pilot research study.

Start: June 2021

Behavioral Economics and Adherence in Teens (BEAT!)

Non-adherence to antiepileptic drug therapy is a significant problem for adolescents with epilepsy and has a critical impact on health and patient-reported outcomes. Evidence-based adherence interventions are lacking in this population and are critically needed. This proposal seeks to develop and evaluate a mHealth social norms adherence intervention for adolescents with epilepsy.

Start: September 2019

Pediatric EEG Monitoring

The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

Start: January 2021

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus 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.

Start: March 2021

Energy Expenditure and Quality of Life in Epilepsy

The main objectives of this study are to investigate the influence of the ketogenic diet (KD), standard care for patients assisted in the UW Health Adult Epilepsy Dietary Therapy Clinic, on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass and fat-free mass in adults with epilepsy. To achieve this objective, twenty-five male and female participants between the ages of 18 and 45 years (or over 18 years for remote participation), who accepted to initiate the KD as a standard of care prescribed by their physician, will be recruited according to inclusion/exclusion criteria. Participants will be on study for 6 months.

Start: June 2021

Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients

Many studies have reported a disparity in medication adherence among epileptic patients. In this population, Medication Possession Ratio (MPR) is an index of medication adherence. MPR is defined as the ratio of the number of days of treatment delivered to the number of days in the period of interest. No-adherents patients are defined by a MPR of less than 80% , in whom an increase in seizures and the rate of hospitalization can be observed. A pharmacist-led intervention and medication information to epileptic patients could improve patient medication adherence to antiepileptic drugs, and possibly decrease the frequency of seizures, hospitalizations and the health costs generated by these hospitalizations. This intervention could also improve patient knowledge about their medications. The aim of this study is to evaluate the effectiveness of a pharmacist-led intervention on medication adherence of epileptic patients with the MPR. Secondary objectives include the comparison of medication adherence with health insurance score, the evaluation of patients knowledges about their medications, community pharmacists' satisfaction about community hospital network, the comparison of the seizure free patient rate and the comparison of the rate of patient in whom seizure have decreased by 50%

Start: September 2021

Self-management for People With Epilepsy

SMART is a program for adult individuals with sub-optimally controlled epilepsy. It involves educational and behavioral interventions intended to enhance epilepsy self-management. The initial group session is in-person where individuals receive curriculum materials and learn to utilize the Web format (such as Adobe Connect or ZOOM) and a teleconferencing service needed to access the remainder of the group sessions. These sessions are held over an 8 week time period and are co-lead by a trained nurse educator and a trained peer educator. The peer educator is someone with epilepsy and a history of NHEs. Educators use a written curriculum delivered online, and the interactive sessions last 60-90 minutes. Groups are limited to about 6 -12 adult participants. After the group sessions are done, individuals have 8 telephone maintenance sessions with the nurse educator and the peer educator spaced approximately 2 weeks apart. SMART is intended for adults with epilepsy, especially those who belong to disadvantaged sub groups such as rural populations, veterans with epilepsy and those who are underinsured. People with epilepsy who belong to disadvantaged sub-groups are more likely to have poor outcomes and often end up using expensive crisis-oriented care, and thus potentially might benefit the most from self-management programs if they can be actively engaged.

Start: May 2021

XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy

To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).

Start: March 2021

Carbon Dioxide (CO2) Chemosensitivity and SUDEP

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.

Start: December 2019

Treating Postictal Symptoms Using Ibuprofen and Nifedipine

This study will evaluate the effect of ibuprofen or nifedipine on post-seizure hypoperfusion and neurological deficits in patients with epilepsy. One group will receive ibuprofen, another will receive nifedipine, and anther placebo.

Start: February 2021

Prevalence of Epilepsy and Sleep Wake Disorders in Alzheimer Disease

Alzheimer disease is the most common of the neurodegenerative diseases. Epilepsy and sleep wake disorders are co-morbid conditions of Alzheimer disease. The investigators propose a prospective study using long-term EEG monitoring in combination with polysomnography to determine prevalence of epilepsy and sleep wake disorders in Alzheimer disease, and correlate these findings with clinical data, Alzheimer disease biomarkers and imaging studies (MRI and amyloid/tau-PET). In selected patients, the investigators will perform EEG studies with foramen ovale electrodes. The ultimate goal is to improve the outcome of patients with Alzheimer disease by early treatment of epilepsy and restoring sleep-wake disturbances.

Start: December 2020

Sensor-Dot and Plug 'n Patch Study in Epilepsy

The investigators plan to determine whether it is possible to use a small, unobtrusive wearable device (the Sensor Dot with Plug 'n Patch system) to follow-up epilepsy in the home environment through measurement of different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for prolonged periods in patients with epilepsy. If this is possible, the investigators will study the chronobiology of epilepsy.

Start: March 2021

VNS Prospective Neuromodulation of Autonomic, Immune and Gastrointestinal Systems

Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of efficacy is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune, gastrointestinal and autonomic systems. The primary objective of this study is to characterize the pre- and post-operative bowel habits and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre- and post-operative autonomic profile, (2) characterize the pre- and post-operative immune profile, and (3) to elucidate whether gut microbiota changes are related to VNS efficacy for epilepsy.

Start: April 2021

Single Neurons Responses During Visual Recognition in Epileptic Patients

The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients. Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

Start: May 2016

An Investigation of Levetiracetam in Alzheimer's Disease

The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial. Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK) as a first line treatment for focal epilepsy. Levetiracetam is now generic and acts, as all anti-epileptic medications do, by stabilising neuronal networks. However, Levetiracetam appears unique amongst the anti-epileptic medications in being able to stabilise aberrant neuronal networks in Alzheimer's disease. In both animal models of AD and in patients with mild cognitive impairment, Levetiracetam can offer benefit to cognition. The investigators therefore aim to test whether Levetiracetam, through stabilisation of neuronal networks, may offer benefit to cognition in patients with AD.

Start: October 2018

Optimization of Human Cortical Stimulation

We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.

Start: September 2010

Understanding Ketamine's Dissociative Effects (KD Study)

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Start: August 2021

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care

Start: February 2018

A Wireless EEG Patch for Continuous Electrographic Monitoring

This proposal will evaluate an individual-use, patch-type telemetry device for simplified, single-channel EEG recording from human patients along-side the traditional in hospital wired EEG.

Start: May 2018

Exercise as Adjunctive Treatment for Refractory Epilepsy

The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

Start: April 2021