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Epilepsy clinical trials

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NCT ID: NCT05747001 Completed - Epilepsy Clinical Trials

This is a Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in Patients Suffering From Epilepsy in Early Access Program in Germany, France and UK

CENOR
Start date: January 27, 2023
Phase:
Study type: Observational

Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients. The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.

NCT ID: NCT05741541 Completed - Epilepsy Clinical Trials

How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?

MAPE
Start date: February 24, 2023
Phase:
Study type: Observational

The goal of this observationnal study is to identify the informative and educational needs of epilepsy patients to avoid interrupting the therapeutic pathway. The main question it aims to answer are : - Identify the patient's expectations of a nurse specializing in epilepsy in the areas of information, predictive elements of good care and adaptation to their state of health - Identify under-addressed or misunderstood themes - Identify patient resources and interventions already in place - Ensuring better continuity of care - Improve the knowledge of patients and their relatives about the management of their pathology After a consultation with the neurologist (as part of their usual follow-up), the participants will be referred to a nurse for a semi-directive, individual interview, lasting 30 minutes and composed of open and closed questions. The announcement of the diagnosis, the quality of life or the factors contributing to the difficulties and their repercussions on a daily basis will be discussed during the interview.

NCT ID: NCT05740423 Recruiting - Epilepsy Clinical Trials

Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy

ADORE
Start date: August 30, 2021
Phase:
Study type: Observational [Patient Registry]

The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

NCT ID: NCT05739669 Recruiting - Epilepsy Clinical Trials

DigitalEPI - A Prospective Pilot Study

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Not all patients with epilepsy requiring advanced checkups in specialized tertiary centers can be admitted for long-term video EEG monitoring. Home EEG recordings or home EEG monitoring using self-applicable EEG recording systems would therefore help overcome an unmet need in the treatment of such patients. Dry electrode EEG systems are more user-friendly than wet electrode EEG systems. In this study, the quality of EEG recordings with a novel dry electrode EEG system (Atlas with dry electrodes) will be compared with the quality of recordings with a conventional wet electrode EEG system used in clinical practice. Secondly, the quality for medical reporting of self-recorded EEG at home by patients with the dry electrode EEG system (Atlas with dry electrodes) will be compared to recordings with the same system in a clinician's office by specialized staff. Thirdly, there will be an exploratory assessment of the value for diagnostics of EEG data from multiple home-recorded dry electrode EEGs, automatic analysis of those recordings and data from a wrist device. The patients that fulfill inclusion criteria and do not meet exclusion criteria will all undergo the following: - a visit to a clinic where a health care professional will record (1) their EEG activity for 15 minutes using a CE-certified EEG device with wet electrodes; and immediately after record (2) their EEG activity for 15 minutes using the investigational EEG device "Atlas with dry electrodes" - self-record their EEG activity at home, using the EEG device "Atlas with dry electrodes", at least twice per day, for 14 days; during this phase, continuous non-invasive recordings of bio signals, i.e. heart rate, muscle activity, using the Empatica EmbracePlus device will be recorded and patients will report events or findings in a paper based study diary. - a last visit to the clinic to return equipment, study diary and fill in questionnaires

NCT ID: NCT05738226 Recruiting - Epilepsy Clinical Trials

EpiCare@Home Validation Study for Focal Onset Seizures

Start date: January 23, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures. The device continuously records brain, cardiorespiratory, and physical activity data. The study aims to 1) collect benchmark data for seizure detection algorithm development and validation, and 2) evaluate the performance of the device in clinical and at home workflows. Participants will wear the device during a routine Epilepsy Monitoring Unit (EMU) admission. Additionally, they can continue wearing the device at home after the EMU admission.

NCT ID: NCT05737784 Active, not recruiting - Epilepsy Clinical Trials

A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy

Start date: April 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.

NCT ID: NCT05727943 Active, not recruiting - Clinical trials for Epilepsy Intractable

Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study

CLIOKID
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

In this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined. Subjects will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). The main hypothesis of the study is that 30% of the included subjects will be responders and that the median seizure frequency reduction will be at least 30%.

NCT ID: NCT05725174 Recruiting - Epilepsy Clinical Trials

Volatile Non-Invasive Biomarkers of Epileptic Seizures

VIBES
Start date: January 30, 2023
Phase:
Study type: Observational

Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.

NCT ID: NCT05724719 Recruiting - Epilepsy Clinical Trials

Seizure Recurrence After Unprovoked First Seizure

Start date: August 1, 2023
Phase:
Study type: Observational

One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS. Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood. The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures. 200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG. Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.

NCT ID: NCT05722990 Recruiting - Clinical trials for Epileptic Encephalopathy

Genetic Investigations in Children With Developmental and Epileptic Encephalopathies in Ho Chi Minh City, Vietnam

Start date: March 16, 2022
Phase:
Study type: Observational [Patient Registry]

Early childhood is one of the periods of life in which the risk to develop epilepsy is highest. Besides, genetic causes are much more common in the young. Recently, an ever-increasing amount of genes has been found to be involved in numerous early-onset epilepsies. Thanks to next-generation sequencing (NGS), a diagnosis can now be reached in close to 50% of children with epilepsy and developmental delay. This, in turn, has led to the successful application of the concept of individualized treatment in a growing number of children with epilepsy. Genetic investigations have thus been progressively included in the routine work-up of children with early-onset epilepsies throughout the world, mostly in high-income countries up to now. As a result of a scientific collaboration between pediatric neurology divisions at University Hospitals Geneva (HUG), Switzerland, and Children's Hospital 2 in Ho Chi Minh City (HCMC), Viet Nam, genetic testing of children with early-onset epilepsies followed at the pediatric neurology division, Children's Hospital 2 started at the genetics laboratory of the Vietnam National University in 2017. Aims: Our project aims at establishing the proportion of patients in whom a causal genetic finding can be identified, in a prospective cohort of children with Developmental and Epileptic Encephalopathies (DEE) followed at Children's Hospital 2 (ND2). The investigators also aim at identifying the percentage of these children in whom this approach would change current management. Methods: A series of children diagnosed with DEE and followed at ND2 Hospital, enrolled consecutively. Exome sequencing was applied to all, with biostatistical analyses of a panel of 671 genes involved in epilepsies and developmental disorders performed in parallel at Ho Chi Minh City Vietnam National University and Geneva Genetic Medicine Division. Sanger sequencing confirmation of potentially causal variants in patients, and in parents for familial segregation. Comparison of Vietnamese and Swiss genetic findings, and multidisciplinary discussions in formal Genome Boards. Additional genetic investigations, if deemed necessary in Genome Board sessions. Clinical management adapted to genetic findings wherever applicable, and follow-up according to standard practice. One-hundred-and-fifty patients are expected to participate during the 3-year study period.