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NCT ID: NCT06352476 Active, not recruiting - Epilepsy Clinical Trials

The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith & Wagner & Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced. Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model.

NCT ID: NCT06308185 Active, not recruiting - Epilepsy Clinical Trials

Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations

Start date: June 1, 2021
Phase:
Study type: Observational

Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years. The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures. The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade.

NCT ID: NCT06138847 Active, not recruiting - Clinical trials for Epilepsy; Syndrome, Seizures of Localized Onset

Does Levetiracetam and Carbamazepine Impact the Autonomic Activity of Children With Self-limiting Focal Epilepsy?

levcbz
Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this cross-sectional study is to learn about autonomic cardiac profile changes in children with self-limiting focal epilepsy using levetiracetam and carbamazepine in children with self-limiting focal epilepsy syndrome. The main questions is it aims to answer are: 1. Are heart rate variability and autonomic tone different among healthy controls and children with epilepsy? 2. Does Levetiracetam and carbamazepine affect autonomic tone differently among children with self-limiting focal epilepsy?

NCT ID: NCT05823168 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Seizures and Traumatic Brain Injury Rehabilitation

Start date: January 1, 2021
Phase:
Study type: Observational

post-traumatic seizures (PTS) are a common and debilitating complication of traumatic brain injury (TBI) and could have harmful impact on patient disabilty and rehabilitation outcome. In this multicentric prospective observational study we aimed to evaluate the role on functional outcome of patients admitted to neurorehabilitation unit afther traumatic brain injury of: - newly occurring seizures - prescription of antiepileptic prophylactic therapy The inclusion criteria were the following: 1) age ≥ 18; 2) diagnosis of TBI on presentation; 3) admission to a hospital emergency department within 24 h of injury; 4) admission within one month from the injury to the rehabilitation unit to continue clinical care and rehabilitation program; 5) up to 6 months of observation in rehabilitation setting. Were collected the following variables: gender, medical history, age at occurrence of injury, injury characteristics, fracture site, presence of penetrating TBI, presence of subarachnoid haemorrhage, associated neurosurgical procedures (craniotomy, cranioplasty), neurologic and functional assessments, brain imaging, occurrence of seizure, presence and type of anticonvulsant therapy, death during hospitalization. The investigator analysed through logistic regression variables predictors of risk occurrence of seizure, and neurological and functional outcome, respectively assessed with the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM).

NCT ID: NCT05758129 Active, not recruiting - Clinical trials for Exposure to Polluted Air

Association Between PM2.5 Exposure and Ferroptosis in Seizures Patients

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

This cohort study aims to discover the possible effects of PM2.5 exposures on the Nrf2- dependent ferroptosis pathway in seizure patients. This observational cohort's main question is whether PM2.5 exposures will affect the Nrf2- dependent ferroptosis pathway in seizure patients. Participants will be divided into two groups: the control group and the air pollution to detect the biomarkers of the Nrf2- dependent ferroptosis pathway in seizure patients

NCT ID: NCT05622370 Active, not recruiting - Partial Seizure Clinical Trials

An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions.

Start date: September 13, 2022
Phase: Phase 1
Study type: Interventional

An open label, balanced, randomized, 3×3 latin square design comparing of Brivaracetam sustained-release tablets and Brivaracetam tablets in the oral comparative pharmacokinetic(PK) study in Chinese healthy adult subjects under fasting conditions. Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) Objective: The sustained-release tablets of Brivaracetam (specification: 100mg) developed by Taizhou Overseas Pharmaceuticals Co.,Ltd. were used as the test preparation A(T1), the sustained-release tablets of Brivaracetam (specification: 50mg) were used as the test preparation B(T2), and the Brivaracetam tablets (trade name: BRIVIACT®, specification: 50mg) produced by UCB were used as the reference preparation (R). To compare the blood concentration and main pharmacokinetic parameters between test preparation A(T1) and test preparation B(T2), between test preparation A(T1) and reference preparation, and between test preparation B(T2) and reference preparation, and evaluate the relative bioavailability and sustained release characteristics of test preparation. Objective: To evaluate the safety of China healthy volunteers after oral administration of sustained-release tablets of test preparation A(T1) and B(T2) and reference preparation (R) Brivaracetam tablets on an empty stomach.

NCT ID: NCT05533814 Active, not recruiting - Epilepsy Clinical Trials

A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures

Start date: October 19, 2022
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).

NCT ID: NCT05274035 Active, not recruiting - Epilepsy Clinical Trials

A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Start date: July 2, 2021
Phase:
Study type: Observational

This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.

NCT ID: NCT05257915 Active, not recruiting - Epilepsy Clinical Trials

A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Start date: January 1, 2021
Phase:
Study type: Observational

This study is a real-word clinical trial. The purpose of this study is to evaluate the effectiveness and safety of perampanel as an add-on treatment for epileptic seizure. The enrolled subjects were epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.

NCT ID: NCT05147571 Active, not recruiting - Epilepsy Clinical Trials

RNS System NAUTILUS Study

NAUTILUS
Start date: August 9, 2022
Phase: Phase 3
Study type: Interventional

To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.