Clinical Research Directory

Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy

A VNS longitudinal study focused on pre and post-VNS implantation in order to predict the VNS response and to understand better mechanisms of VNS using some connectivity and network measures.

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

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.

Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients

Although VNS has been widely used in clinic for over 30 years, its mechanisms of action remain unclear and there is a lack of individual biomarkers of efficacy. One potential and understudied source of variability on the response to VNS may be related to nerve function and recovery following implantation. VNS co-activates the recurrent laryngeal branch of the vagus nerve, which carries vagal-Aα fibres innervating all the laryngeal muscles except the cricothyroid. VNS-induced effective activation of the recurrent laryngeal nerve generates a so-called LMEP. Despite the fact that the LMEP represents a simple, non-invasive, and feasible technique to employ in clinical routine, it is not yet sufficiently investigated. This study comprises 5 visits (2 weeks, 1 month, 3 months, 6 months, and 12 months after VNS implantation) and consists of the measurement of the laryngeal-motor evoked potentials induced by vagus nerve stimulation (VNS), that will be further compared with the corresponding clinical response to VNS.

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

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.

Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy

This is a multi-site registry study that aims to collect real-world clinical outcomes and device performance of the OneRF Ablation System. The study focuses on patients with refractory epilepsy who undergo, or are being considered for, sEEG-guided RF ablation using the OneRF Ablation System, as part of routine seizure diagnosis and treatment.

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

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.

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

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.

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

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 compared the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.

Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials

The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol. The main questions it aims to answer are: * Does cannabidiol lower the number of seizure in children with severe epilepsy? * Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities? * What medical problems do participants have when taking cannabidiol? Researchers will compare cannabidiol to a placebo (a look-alike oil that contains no cannabidiol) to see if drug cannabidiol works to treat severe epilepsy. All participants will receive both the cannabidiol and the placebo during different periods. At the end of the trial, we will evaluate for each patient seperately, whether seizures were less or more frequent during cannabidiol periods or placebo periods, to see what works best for every patient seperately. Participants will: * Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided * Take CBD oil during 2 to 3 periods. One period will last around 7 weeks. * Also take placebo oil during the other 2 to 3 periods * Have a blood test every 7 weeks to monitor for safety and possible adverse effects * Visit the clinic once every 15 weeks for checkups and tests * Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.

Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy

The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy.

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

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

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

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.

Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG

The prospective study aims to characterize the network-specific modulatory effects of piriform cortex stimulation in patients undergoing stereotactic EEG for drug-resistant epilepsy. Using multimodal data, it seeks to link stimulation-evoked electrophysiological responses across brain networks with clinical outcomes, to inform targeted neuromodulation therapies.

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.

An Automated Navigation System for Deep Brain Electrode Implantation

1. Analysis of the correlation between imaging and electrophysiological signals. 2. Real time analysis method for optimal implantation position. 3. Simultaneous Imaging and electrophysiology navigation. 4. Accuracy and security verification of navigation system. Expectation(Hypothesis): Develop an automated DBS surgical navigation system based on multimodal brain imaging data and neural electro-physiological signals, which can achieve real-time linkage navigation between imaging and electrophysiology, and automatically generate the optimal implantation position of DBS electrodes based on imaging and electrophysiological information through deep learning algorithms, thereby reducing DBS electrode implantation position errors and improving surgical efficacy.

Atlas of Human Cognition by SEEG (MAPCOG-SEEG)

The main objective of MAPCOG\_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.

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

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.