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Epilepsy clinical trials

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NCT ID: NCT06462911 Not yet recruiting - Epilepsy Clinical Trials

Epilepsy Self-Management for Spanish Speakers: HOBSCOTCH - ESPANOL

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

The goal of this pilot study is to assess the feasibility of translating and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with epilepsy whose primary language is Spanish. The main questions it aims to answer are: 1. Can the current HOBSCOTCH program be successfully translated for Spanish speaking people with epilepsy? 2. Will people with epilepsy who speak Spanish experience improved quality of life similar to that found in people with epilepsy who received the HOBSCOTCH program in English? Participants will be asked to: - attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-SPANISH sessions with a one-on-one certified bilingual HOBSCOTCH coach - complete a brief clinical questionnaire about their diagnosis of epilepsy - complete two questionnaires before and after the HOBSCOTCH sessions about their quality of life and about memory and thinking processes - keep a short daily diary about their seizures, symptoms and use of the self-management strategies taught in the HOBSCOTCH program - complete a brief Satisfaction Survey and a 3 question survey about shared decision making after the entire HOBSCOTCH program

NCT ID: NCT06453213 Not yet recruiting - Focal Onset Seizure Clinical Trials

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Start date: July 18, 2024
Phase: Phase 4
Study type: Interventional

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

NCT ID: NCT06443463 Not yet recruiting - Focal Epilepsy Clinical Trials

Long-term Safety and Tolerability of BHV-7000

Start date: July 2024
Phase: Phase 2
Study type: Interventional

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

NCT ID: NCT06436547 Not yet recruiting - Clinical trials for Epilepsy, Drug Resistant

Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

NCT ID: NCT06427967 Not yet recruiting - Epilepsy Clinical Trials

A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

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

Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically. The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.

NCT ID: NCT06425029 Not yet recruiting - Epilepsy Clinical Trials

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

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

This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.

NCT ID: NCT06424977 Not yet recruiting - Epilepsy Clinical Trials

Biomarker Targeted Stimulation for Epileptiform Events

BTSEE
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.

NCT ID: NCT06422923 Not yet recruiting - Clinical trials for Epilepsy, Temporal Lobe

Effect of NRTX-1001, a Cellular Therapy Product, for the Treatment of Refractory Bilateral TLE

Start date: July 15, 2024
Phase: Phase 1
Study type: Interventional

This study is designed to obtain open-label feasibility, safety, and seizure frequency data in patients with drug-resistant bilateral mesial temporal lobe epilepsy (MTLE) administered NRTX-1001.

NCT ID: NCT06412653 Not yet recruiting - Epilepsy Clinical Trials

Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders

ZINCGNAO1
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. The main questions it aims to answer are: - Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy? - Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients. Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.

NCT ID: NCT06408428 Not yet recruiting - Epilepsy Clinical Trials

Glioma Intraoperative MicroElectroCorticoGraphy

MicroECoGG
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to validate the safety and to assess the quality of the signals provided by newly developed micro ElectroCorticoGraphy electrodes, provided by the company Panaxium, based on conductive polymers (PEDOT:PSS) in patients suffering of gliomas during resection surgery performed in awake condition. The main questions it aims to answer are: - Safety of PEDOT:PSS microECoGs by assessing the rate of serious adverse events associated with their use during glioma surgery. - Quality of PEDOT:PSS microECoGs recordings, as compared with recordings with traditional macroelectrodes, assessed by signal-to-noise ratio, impedance, ability to detect ripples (100-250 Hz) and fast ripples (250-600 Hz), ability to record epileptic activity (spikes and equivalent) either spontaneously or following direct electrical stimulation (afterdischarges). - Practicality of microelectrodes use as perceived by neurosurgeons. - Exploratory objectives: ability to record multi-unit activity, correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations, determination of epileptic seizure rate during electrode use. Participants will be recorded during awake glioma surgery by the newly developed micro ElectroCorticoGraphy electrodes and by routine macroelectrodes, as standard of care during both mapping of cortical activities and electrical stimulations used to assess the functional mapping mandatory for tailored tumor resection.