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Refractory Epilepsy clinical trials

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NCT ID: NCT06304389 Recruiting - Refractory Epilepsy Clinical Trials

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

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

Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.

NCT ID: NCT06241963 Recruiting - Clinical trials for Transcranial Direct Current Stimulation

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.

NCT ID: NCT06141668 Recruiting - Refractory Epilepsy Clinical Trials

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Start date: June 13, 2023
Phase: N/A
Study type: Interventional

Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.

NCT ID: NCT05493722 Recruiting - Clinical trials for Deep Brain Stimulation

Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

Start date: September 15, 2023
Phase: Early Phase 1
Study type: Interventional

Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.

NCT ID: NCT05232630 Recruiting - Refractory Epilepsy Clinical Trials

Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes

FENDEEP
Start date: October 20, 2022
Phase: Phase 4
Study type: Interventional

This study is a pilot non-controlled clinical trial with adjunctive fenfluramine for the treatment of five different types of developmental and epileptic encephalopathies (DEEs) focused on epileptic and "non-epileptic outcomes": SYNGAP1 and STXBP1 encephalopathies, inv-dup(15) encephalopathy, multifocal or bilateral malformations of cortical development, and continuous spikes and waves during sleep. The main goal is to assess changes in seizure frequency comparing before and after treatment with fenfluramine in five specific types of developmental and epileptic encephalopathies (DEEs). Secondary objectives of this study are the analysis of changes in seizure intensity and duration, and "non-epileptic outcomes" such as variations in cognitive activity, level of alertness, impulsivity/self-control, gait stability and other alterations that might be detected during the interview and physical examination.

NCT ID: NCT05019885 Recruiting - Clinical trials for Drug Resistant Epilepsy

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Start date: August 26, 2022
Phase: Phase 2
Study type: Interventional

Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief. Recently, Ketamine was approved to treat drug resistant depression using subanesthetic doses. In the hospital setting, intravenous anesthetic dosages are used to treat unrelenting seizures known as status epilepticus in comatose patients. Ketamine in subanesthetic doses has not been tried as a treatment for medication resistant seizures in the outpatient setting. This study would like to examine the effectiveness of subanesthetic ketamine in outpatients who suffer from drug resistant epilepsy.

NCT ID: NCT04833322 Recruiting - Refractory Epilepsy Clinical Trials

Galactose Supplementation for the Treatment of MOGHE

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

Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.

NCT ID: NCT04771065 Recruiting - Refractory Epilepsy Clinical Trials

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy

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

Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.

NCT ID: NCT04770337 Recruiting - Epilepsy Clinical Trials

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

NCT ID: NCT04684797 Recruiting - Refractory Epilepsy Clinical Trials

Localization of the Reward Positivity to ACC

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many others, but nobody knows what it actually does. Recently a new theory has been developed about ACC function; the HRL-ACC (Hierarchical Reinforcement Learning Theory of ACC). This theory proposes that the ACC selects and motivates high-level tasks based on the principles of hierarchical reinforcement learning. The ACC associates values with tasks, selects the correct tasks and applies control over other neural networks (such as the dorsolateral prefrontal cortex and basal ganglia), which execute the tasks. The values of these tasks are attributed based on "reward prediction error signals", which are sent from the midbrain dopamine system to the ACC. These signals can be recorded using scalp-EEG as an "event-related brain potential" (ERP), which is called the "reward positivity". Until this day, the exact origin of the reward positivity is not yet known. Studies have delivered strong indirect evidence that the reward positivity is generated in the ACC. However, there is an important lack of direct evidence to support this hypothesis. The goal of this study is to provide direct evidence that the reward positivity is generated in the ACC by letting a group of patients with refractory epilepsy perform the virtual T-maze task (which is known to elicit reward positivity) and simultaneously recording intracranial video-EEG.