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Epilepsy clinical trials

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NCT ID: NCT05407727 Completed - Epilepsy Clinical Trials

A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy

Start date: April 15, 2022
Phase:
Study type: Observational

This prospective observational study is designed to assess the individualized baseline disease burden in pediatric participants aged 1 year to 16 years, with early-onset SCN2A-DEE by characterizing and quantifying changes in clinical features over a period of up to 12 months.

NCT ID: NCT05384782 Completed - Epilepsy Clinical Trials

Computational Decision Support in Epilepsy Using Retrospective EEG

Start date: December 1, 2019
Phase:
Study type: Observational

The primary aim is to validate a set of computational biomarkers as potential decision support in epilepsy on a large cohort of study participants that were diagnosed with epilepsy and controls that ended up with another diagnosis (such as syncope or non-epileptic seizures). The goal is to examine if the methodology works robustly on this large cohort, and can theoretically contribute to the reduction of misdiagnosis rates. The secondary aim is to examine whether the computational biomarkers could contribute to reducing the waiting time and the number of clinical appointments needed before a final diagnosis is made.

NCT ID: NCT05364021 Completed - Dravet Syndrome Clinical Trials

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

PACIFIC
Start date: March 3, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.

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: NCT05325047 Completed - Epilepsy Clinical Trials

Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study

REPREO SCED
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Out of 30,000 new cases per year in France, 30% of epileptic patients are drug-resistant. Neurosurgery, which consists in resecting the epileptogenic zone, is the only chance of cure. In the case of temporal epilepsy of the language-dominant hemisphere (TLE), this procedure presents a high risk of increasing cognitive difficulties and may even be contraindicated for this reason alone. The difficulties found are impairments in lexical access (anomia) and verbal memory and affect more than 60% of patients. Preoperative cognitive rehabilitation could influence brain plasticity mechanisms but there are currently no recommendations on this topic. In this context, a speech rehabilitation procedure specific to the needs of ELTPR patients was developed. Investigators rely on cognitive hypotheses explaining the disorders but also on models of rehabilitation-induced neural plasticity likely to improve cognitive reserve before surgery. Investigators hypothesize that preoperative cognitive language rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative language prognosis. The main objective is to demonstrate the efficacy of preoperative speech therapy on language performance and to evaluate possible protective effects on postoperative language prognosis. Single case study following the Single Case Experimental Design (SCED) methodology involving the prior definition of the following elements: a repeated measure of the target behavior (naming abilities), the sequential introduction of an intervention (speech therapy), whose effect will be evaluated according to SCED specific analysis and statistics (visual analysis, Tau -U, randomized tests). Investigators expect patients' naming performance to be stable before the introduction of speech therapy. It is expected that patients will progress in the trained words from the beginning of speech therapy. Finally, in the postoperative period, investigators predict that for the trained words, patients will show performances superior or equal to the pre-rehabilitation period. This result would support a protective effect of preoperative speech therapy.

NCT ID: NCT05317091 Completed - Hypertension Clinical Trials

The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period

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

This study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.

NCT ID: NCT05297695 Completed - Clinical trials for Helicobacter Pylori Infection

Helicobacter Pylori Eradication Therapy for Epileptic Children

Start date: April 20, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Helicobacter pylori (H. pylori) infection is associated with several health problems. The role of H. pylori infection in epilepsy has been investigated in a few studies. To the best of our knowledge, there have been no previous studies on the effect of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy. This study aims to evaluate the effect of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy.

NCT ID: NCT05296057 Completed - Epilepsy Clinical Trials

Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety

AnxEpiVR
Start date: March 24, 2023
Phase: N/A
Study type: Interventional

Over 28% of people with epilepsy (PwE) struggle from at least one anxiety disorder, making anxiety the most common psychiatric comorbidity in this population. Despite the importance of treating anxiety in PwE, it has not received much research attention and is often unrecognized and untreated. Research has suggested that including exposure therapy (ET) as a part of an anxiety treatment may be helpful for decreasing anxiety in PwE. Research has also shown that Virtual Reality (VR) is an effective and helpful tool for delivering ET in a number of different types of anxiety disorders, such as posttraumatic stress disorder, panic disorder, and social anxiety disorder. To the investigators' knowledge, no research has been conducted to-date on using VR to deliver ET (VR-ET) in PwE. People with epilepsy have commonly been excluded from VR studies due to the concern that it may trigger seizures in people with photosensitive epilepsy. Although limited research is available on the use of VR in PwE, hesitations regarding the use of VR in this population have not been substantiated and clinicians and researchers are increasingly considering VR for use in this population. The use of an immersive VR head-mounted display to deliver ET in this population offers several benefits. For example, studies suggest that VR-ET is an especially useful method for customized treatment when it is not safe or practical to do exposures. This is important to consider as it may not be practical to do exposures in-person during times of pandemic, such as the COVID-19 pandemic. Even outside of the pandemic, VR reduces the need for travel, which is difficult for PwE in normal circumstances as driver's licences are typically suspended after a confirmed seizure. Using VR for ET as opposed to traditional ET can also save money and time, and allow for more equitable access to healthcare resources for those who may not live in urban centers. The investigators designed and will be rigorously evaluating a VR-ET program administered in private residences specific for PwE that focuses on decreasing anxiety that is specifically related to their epilepsy or seizures. This study would be among the first to evaluate VR-ET in this population. This study will also contribute to the limited body of research that currently exists managing comorbid anxiety in PwE as well as the minimal existing literature about fears specifically related to epilepsy or seizures. The overall primary objective of this study is to report on the feasibility and appropriateness of the protocol and evaluation instruments for use in the subsequent larger clinical trial. The secondary objective is to evaluate whether VR-ET reduces epilepsy- or seizure-related anxiety in PwE. It is hypothesized that PwE will experience decreased levels of epilepsy-related anxiety after undergoing VR-ET. These findings will be used to inform a future randomized controlled trial.

NCT ID: NCT05276271 Completed - Epilepsy Clinical Trials

The Effect of Levetiracetam on Lipid Profile in Children

Start date: October 1, 2020
Phase:
Study type: Observational

Levetiracetam is a widely prescribed antiseizure medication in epileptic children due to an estimated better safety profile and easy accessibility. There is limited and contradicting data about the effect of levetiracetam on serum lipid metabolisms, especially in epileptic children. The aim of our study was to evaluate the effect of levetiracetam therapy on lipid metabolism in euthyroid non-obese epileptic children. In this case-control study, the investigators recruited 37 epileptic children receiving levetiracetam monotherapy for at least 12 months and 54 healthy controls. All the participants were euthyroid and within normal nutritional status limits for their age. Fasting blood samples were obtained for serum thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine, total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, Triglyceride/HDL Index, uric acid, CRP, and transaminases at the administration. The investigators would like to show if epileptic children with levetiracetam monotherapy are susceptible to lipid metabolism alterations.

NCT ID: NCT05273398 Completed - Epilepsies, Partial Clinical Trials

Effects of Diazepam on RNS Detections

Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.