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Epilepsy clinical trials

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NCT ID: NCT03478982 Completed - Epilepsy Clinical Trials

Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern

StATES
Start date: March 16, 2018
Phase: Phase 2
Study type: Interventional

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 study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).

NCT ID: NCT03478852 Recruiting - Epilepsy Clinical Trials

Investigating Epilepsy: Screening and Evaluation

Start date: March 28, 2018
Phase:
Study type: Observational

Background: Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy. Objectives: To learn more about seizures and find ways to best treat people with drug-resistant epilepsy. Eligibility: Adults and children ages 8 years and older with diagnosed or suspected epilepsy Design: Participants will be screened with: Physical exam Medical history Questionnaires Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed. Participants will have many tests: Blood and urine tests EEG: Wires attached to the head with paste record brain waves. This may be videotaped. Thinking and memory tests MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube. MEG: Participants lie on a table and place their head in a helmet to record brain waves. PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle. Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.

NCT ID: NCT03475225 Not yet recruiting - Clinical trials for Drug Resistant Epilepsy

Vitamine D in Drug Resistant Epilepsy

EPI-D
Start date: April 2018
Phase: Phase 3
Study type: Interventional

Almost all patients with epilepsy living in the region of Paris have vitamin D deficiency, which is severe in 1/3 of the cases. The impact of this deficiency on epilepsy is unknown, despite the suggested benefits of vitamin D therapy including better seizure control and improvement of comorbidities (fatigue, anxiety, depression) in drug-resistant patients. Recommendations for vitamin D supplementation based on the serum level in the general population cannot be applied to patients with epilepsy due to interference of antiepileptic drugs in the vitamin D metabolism. Animal models, mechanisms of action studies and ecological information provide objective data for a direct antiepileptic effect of vitamin D. Human studies seem to confirm the antiepileptic effect of vitamin D but there are no controlled studies on large populations. The investigators aim to assess prospectively the effect of the treatment of vitamin D deficiency providing a high level of evidence. The investigators propose a multicentre placebo controlled randomized double-blind study, testing vitamin D supplementation against placebo in 400 drug-resistant patients to assess the short-term (3 months) and long-term (1 year) benefits on epilepsy. The investigators hypothesize that the treatment of vitamin D deficiency will result in significant reduction of seizure frequency, and improvement of comorbid symptoms as well as quality of life. The impact on the care of patients is important because better epilepsy control allows reduction of the antiepileptic drugs and side effects. This again is a key for the recovery of social and professional activities, and reduction of costs related to the disease.

NCT ID: NCT03471481 Terminated - Epilepsy Clinical Trials

Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy

Start date: August 10, 2015
Phase:
Study type: Observational

The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.

NCT ID: NCT03465566 Recruiting - Epilepsy, Rolandic Clinical Trials

Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)

BECTS
Start date: November 1, 2018
Phase:
Study type: Observational

The social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Accordingly, children with early onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.

NCT ID: NCT03465189 Completed - Epilepsy Clinical Trials

Validation of a Seizure Monitoring System

Start date: September 10, 2018
Phase:
Study type: Observational

The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.

NCT ID: NCT03465163 Completed - Epilepsy Clinical Trials

A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

Start date: March 27, 2018
Phase: N/A
Study type: Interventional

The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.

NCT ID: NCT03464487 Recruiting - Clinical trials for Drug Resistant Epilepsy

Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.

NCT ID: NCT03464383 Completed - Depression Clinical Trials

Anxiety and Depression in Epilepsy: A Treatment Study

Start date: May 7, 2018
Phase: Phase 4
Study type: Interventional

As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. Patients that do not meet eligibility requirement or decline the study intervention will have the option of participating in the survey arm of the study. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist. Participants in the survey arm of the study will complete a one time survey.

NCT ID: NCT03464370 Recruiting - Epilepsy Clinical Trials

Evaluation of Stress Sensitivity and Hyperemotivity in Epilepsy Compared to and a Group of Healthy Volunteers

STELLA
Start date: March 8, 2018
Phase: N/A
Study type: Interventional

Recently, a possible subtype of temporal lobe epilepsy (TLE) has been proposed: this subtype presents ipsilateral amygdala enlargement (AE) without any other lesion. However, little is known about its clinical and psychiatric phenotype. The amygdala seems to play a major role in stress related disorders (including perception of stress). The hypothesis in this study is that patients with TLE-AE more frequently report emotional distress as a seizure-precipitating factor than any other epileptic patient.