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Epilepsy clinical trials

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NCT ID: NCT06252532 Not yet recruiting - Epilepsy Clinical Trials

Causal Role of Top-Down Theta Oscillations in Prioritization

Start date: February 2024
Phase: N/A
Study type: Interventional

Purpose: The purpose of this pilot study is to investigate the dynamics between theta and alpha oscillations in the control of working memory. These findings will be informative of what types of brain stimulation are most effective at modulating brain activity. Deep brain stimulation and transcranial magnetic stimulation are used for an increasing number of neurological and psychiatric disorders. Participants: Eligible participants are patients who have previously had electrodes implanted to monitor epilepsy (outside of research activity). 50 participants will be recruited, 25 participants for each phase of the study. Procedures (methods): The participants will perform a cognitive control task. During the task, rhythmic trains of direct cortical stimulation will be delivered to the frontal cortex alone or to the frontal and parietal cortex. Electrocorticography will be collected concurrent with stimulation.

NCT ID: NCT06210022 Not yet recruiting - Epilepsy Clinical Trials

Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy

Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study. Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2). High-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns. Cognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioural disturbances in these patients.

NCT ID: NCT06205160 Not yet recruiting - Focal Epilepsy Clinical Trials

Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

EpiGrid
Start date: April 2024
Phase: N/A
Study type: Interventional

The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery. Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.

NCT ID: NCT06195020 Not yet recruiting - Clinical trials for Examining the Effect of Metaverse-based Epilepsy Education on Parents' Knowledge Level

Examining the Effect of Metaverse-Based Epilepsy Education

Start date: January 2024
Phase: N/A
Study type: Interventional

The research is a randomized controlled experimental study and was planned to examine the effect of metaverse-based epilepsy education on the epilepsy knowledge level of parents.

NCT ID: NCT06194916 Not yet recruiting - Epilepsy Clinical Trials

The Effect of Web-based Education Provided According to the Health Promotion Model on Self - Management in Epilepsy Patients

Start date: March 2024
Phase: N/A
Study type: Interventional

Epilepsy is a disease that requires long-term treatment and follow-up. Epilepsy To be successful in management, the educational needs of the patient must first be determined and the individual Treatment compliance should be increased by ensuring self-management of the disease.Interventions planned based on the model in patient education direct caregivers to specific goals and provide more planned, coordinated and safe care. The Health Promotion Model (HGM), developed by Nola Pender, is one of the models used to explain health protection and promotion behaviors. It is not aimed at preventing any disease or disability, but aims to improve health, in other words, to further increase the general health and well-being of the individual. H0: Web-based education given to epilepsy patients according to the Health Promotion Model has no effect on self-management. H1: Web-based education given to epilepsy patients according to the Health Promotion Model has an effect on self-management. Research Inclusion Criteria: 1. Individuals who agree to participate in the research 2. Being over 18 years of age 3. Having been diagnosed with epilepsy for at least 1 year 4. Being able to use technological devices (phone, computer, tablet) 5. Having internet access, 6. Being able to speak Turkish, 7. Not having any additional disease 8. Being literate When starting the study, patients who apply to the outpatient clinic and meet the inclusion criteria will be given an explanation about the purpose of the research and how the research process will work. Then, written consent will be obtained indicating that they agree to participate in the study. Pretest data will be collected online. "Personal Information Form" and "Epilepsy Self-Management" scale will be used for individuals in the control and experimental groups to collect data. In preparing the infrastructure of the web-based training program, a website called "Epilepsy Training Program" will be created with support from a professional computer engineering company. The training will include topics such as epilepsy, seizure management, medication management, safety management and lifestyle management. A training program consisting of presentations and videos will be offered on the website for a total of 4 weeks. 3 months after the training is completed, the "Epilepsy Self-Management Scale" will be applied to the experimental and control groups as a posttest.

NCT ID: NCT06194422 Not yet recruiting - Clinical trials for Psychiatric Comorbidities

Psychiatric Comorbidities in Children With Generalized Epilepsy

Start date: December 30, 2023
Phase:
Study type: Observational

Epilepsy is defined as a chronic disorder that presents with recurrent episodes of unprovoked seizures. Epileptic seizures are caused by excessive excitation of cortical neurons. The condition has various etiologies and comorbidities. Classification; The Classification of Epilepsies includes several diagnostic levels (steps): 1. from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown) 2. etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification

NCT ID: NCT06180538 Not yet recruiting - Epilepsy Clinical Trials

Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

EPIVIEWS
Start date: January 2024
Phase:
Study type: Observational

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

NCT ID: NCT06175247 Not yet recruiting - Epilepsy Clinical Trials

Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are: - Is the low glycemic index tolerable in pregnant people with epilepsy? - Does the low glycemic index alter seizure frequency in pregnant people with epilepsy? - Does the low glycemic index alter the gut bacteria & associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition & metabolites differ.

NCT ID: NCT06139198 Not yet recruiting - Epilepsy Clinical Trials

Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.

SMART
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of self management intervention for reducing epilepsy burden among Ugandans with epilepsy (SMART- U) vs. enhanced treatment as usual (eTAU) via an RCT in adults with epilepsy. The main question[s] it aims to answer are: - What is the efficacy of SMART - Uganda (SMART-U) versus enhanced treatment as usual (eTAU) among PWE? - How does short message service (SMS) delivered by mobile phone text validate self-reported seizure occurrence? Participants will be randomly (1:1 basis) assigned to receive either SMART-U (N=94) or eTAU (N=94) using block randomization. SMART-U will consist of 2 main components: a 12-week "intensive" group format stage and a 12-week remotely accessed telephone follow-up stage. Individuals randomized to eTAU will continue in their usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic. If there is a comparison group: We will compare the mean change in seizure frequency and quality of life from baseline and 24 weeks of follow up.

NCT ID: NCT06135285 Not yet recruiting - Epilepsy Clinical Trials

Korus: a Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)

Korus
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are: - Can Korus accurately detect body position in bed (left, right, supine, prone) - Can Korus reposition the subject from a prone to recovery (sideways) position? Participants will be asked to lie down on Korus and turn into various positions; when the prone position is detected, they will be repositioned.