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Seizures clinical trials

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NCT ID: NCT05612763 Completed - Clinical trials for Hearing Loss, Sensorineural

Self Fitting Hearing Aid Clinical Investigation

Start date: August 18, 2022
Phase: N/A
Study type: Interventional

Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

NCT ID: NCT05605301 Completed - Epilepsy; Seizure Clinical Trials

Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy

Start date: September 2, 2022
Phase: Phase 2
Study type: Interventional

This project studies how 2-deoxy-glucose (2DG) pills are absorbed and distributed in people with epilepsy. 2DG is similar to glucose, the main energy source for the brain, but it cannot be used as energy. During seizures, neurons are at a very high metabolic state with huge glucose metabolism as glycolysis is accelerated to supply the high metabolic needs of a seizure. 2DG is taken up by cells but cannot be metabolized by the first enzyme in the glycolytic pathway, thus is stops, or "clogs up", glycolysis. Since brain metabolism is almost entirely dependent on glucose as an energy source, glycolysis is arrested and may stop seizures. It is hoped that 2DG will stop seizures by interfering with the brain's energy use. This is an open-label phase 2 study of the pharmacokinetics (PK), safety, and tolerability of 2DG administered orally to adult epilepsy patients. A 3-level 2DG dose escalation is planned in sequential cohorts of 3 subjects in each cohort with review of each cohort before proceeding to the next cohort. On the day of oral 2DG exposure, subjects will receive a single dose of 40 mg in the first cohort, a single dose of 60 mg in the second cohort, and two 60 mg doses (60 mg bid) in the third cohort. After 3 subjects have completed dosing at Dose Level 1 (40 mg/day), the safety and PK results will be reviewed. The Study Committee will determine if the next cohort should be enrolled at Dose Level 2 (60 mg/day). The same procedure will be repeated to determine if the next cohort should be enrolled at Dose Level 3 (60 mg bid = 120 mg/day). If the Study Committee determines that the most recent dose is not tolerated or that there are significant adverse events, the subsequent Dose Level will not be enrolled. A standard time-concentration curve will be constructed from the 2DG levels obtained from the PK blood draws. Parameters will be calculated for: time to maximum concentration (tmax), maximum concentration (Cmax), elimination rate, half-life (t1/2), AUC, and derived parameters. Statistical analysis will not be performed because of the small n, but this will nevertheless establish the PK profile of 2DG in people with epilepsy. The most important parameter will be the AUC which determines drug exposure.

NCT ID: NCT05500638 Completed - Epilepsy Clinical Trials

Effect of VR-ESMEPP on Parents' Seizure Management

VR-ESMEPP
Start date: August 6, 2018
Phase: N/A
Study type: Interventional

Objective: This study aims to evaluate the knowledge, skills, and motivation of parents regarding management of epileptic seizures, by developing a "Virtual Reality Based Seizure Management Education Program for Parents (VR-ESMEPP). Method: This study is a double-blinded, pretest-posttest, observational randomized controlled study. The administration stage of the study was conducted between September 2018-February 2020 with parents of 91 children who were diagnosed with epilepsy and were being followed in the Pediatric Neurology Outpatient Department of Akdeniz University Hospital. The parents were distributed into groups with simple randomization (VR Group n=45-Control Group n=46). During the preparation stage of the study, data collection tools "Management-of-Epileptic Seizure-Training-Program-Prepared-with-Virtual-Reality-Technology" and "Patient Scenario Regarding Secondary Generalized Tonic-Clonic Epileptic Scenario with Aura" were prepared and integrated into the virtual reality glasses. In the administration stage, the intervention group was administered the pretest, then the training program, and a posttest immediately following the training. The participants were monitored on the 15th day. For the control group, a pretest, routine outpatient clinical practices, and a posttest were carried out; and the participants were monitored on day 15. In both groups, data were obtained with data collection tools that were integrated into the virtual reality glasses. An approval from the Ethics Committee of Akdeniz University, a written permission from the Akdeniz University Hospital, and informed consent from the parents were obtained to conduct the study.

NCT ID: NCT05408000 Completed - Clinical trials for Electroconvulsive Therapy

Comparision of Motor Seizure Duration of Ketofol and Propofol for Electroconvulsive Therapy

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Propofol is routinely used in our hospital for ECT. It causes hypotension and has anticonvulsant actions. Use of ketofol ( 1:1 combination of ketamine and propofol) during ECT can have longer seizure duration and better hemodynamics than propofol alone which ultimately leads to better therapeutic efficacy. Motor seizure duration of minimum 20-25 seconds is usually recommended for therapeutic efficacy of ECT.Patients planned for electroconvulsive therapy meeting the inclusion criteria and not having exclusion criteria will be randomized into two groups. Group K will receive titrated dose of Ketofol and Group P will receive titrated dose of Propofol for induction of anaesthesia

NCT ID: NCT05341713 Completed - Clinical trials for Vaccine Adverse Reaction

Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

Start date: January 1, 2022
Phase:
Study type: Observational

Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study. Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.

NCT ID: NCT05259891 Completed - Epilepsy Clinical Trials

eegCap Application in Paediatrics wiTh redUced GCS in REsus

CAPTURE
Start date: July 5, 2021
Phase:
Study type: Observational

Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

NCT ID: NCT05257811 Completed - Sleep Clinical Trials

Earbud EEG Feasibility Study

PRIME
Start date: September 1, 2019
Phase:
Study type: Observational

The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.

NCT ID: NCT05246904 Completed - Clinical trials for Hearing and Vision Loss

Validating a Self-fitting Hearing Aid

Start date: March 17, 2022
Phase: N/A
Study type: Interventional

Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.

NCT ID: NCT05241366 Completed - Clinical trials for Psychogenic Non-Epileptic Seizure

TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to compare the effect of Transcranial Magnetic Stimulation (TMS) versus treatment with selective serotonin reuptake inhibitors (SSRIs), in patients with diagnosis of Functional Neurological Non Epileptic Seizure Disorder (PNES).

NCT ID: NCT05219006 Completed - Ketogenic Dieting Clinical Trials

Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to determine the effects of the ketogenic diet on the frequency of non-epileptic seizures in patients with functional neurological symptoms disorder compared to a healthy diet.