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Focal Epilepsy clinical trials

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NCT ID: NCT05673915 Recruiting - Focal Epilepsy Clinical Trials

Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.

NCT ID: NCT05635396 Not yet recruiting - Focal Epilepsy Clinical Trials

Seizures Detection in Real Life Setting

ECEME
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities. Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients. Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising. Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence. This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).

NCT ID: NCT05497193 Active, not recruiting - Focal Epilepsy Clinical Trials

Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

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

This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.

NCT ID: NCT05481905 Withdrawn - Focal Epilepsy Clinical Trials

ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures

ENACT
Start date: September 2022
Phase: Phase 2
Study type: Interventional

The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.

NCT ID: NCT05278221 Recruiting - Focal Epilepsy Clinical Trials

TMS Combined With EEG/EMG as a Biomarker Predicting Antiepileptic Drug Response

BIOEPI
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Ιn the present study (BIOEPI), the following three hypotheses will be investigated: 1. The proposed TMS-EEG / EMG protocol (which includes software for calculating the cerebral cortex stimulation threshold) in combination with advanced signal analysis and data mining methods will allow the detection of the effect of antiepileptic drugs (AED) with different mechanisms of action (lacosamide & brivaracetam) in the Central Nervous System under healthy and pathological conditions (Epilepsy). 2. AED-induced changes in selected TMS-EEG / EMG features predict the clinical response of individual epileptic patients to AED. 3. AED-induced changes in selected TMS-EEG / EMG features may predict cognitive side effects.

NCT ID: NCT05198882 Recruiting - Epilepsy Clinical Trials

Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy

EPILITT
Start date: July 4, 2022
Phase: Phase 1
Study type: Interventional

Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance.

NCT ID: NCT05180916 Recruiting - Focal Epilepsy Clinical Trials

Priming the Epileptic Brain: tVNS to Improve Efficacy of add-on AED in Patients With Focal Epilepsy

PREP
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The most prevalent neurological disorder with also immense burden of disease, epilepsy, is in over 30 percent of patients difficult to treat. The ideal treatment regime would give complete control of disease in an early stage, not only for patient well-being, but also to prevent the onset of persistent pathologic epileptic networks in the brain. The first step in treatment is the trial, and error, of multiple anti-epileptic drugs (AEDs), while invasive brain stimulation (BS) techniques with network modulating properties are saved as a last resort. The investigators hypothesize that pharmacotherapeutic treatment of epilepsy can be more successful after "priming" (preparing) the brain using BS as a short-term neuromodulation treatment. The limitation of testing this hypothesis is the invasive aspect of the most used classic vagal nerve stimulation (VNS) treatment for epilepsy, but the recent development of transcutaneous vagal nerve stimulation (tVNS) offered a possibility to combine chemical and electrical modulation in an earlier stage of disease, which is not tested before. The investigators want to determine the priming effect on the epileptic brain of tVNS, to make it more susceptible to add-on treatment with Brivaracetam (BRV), an AED. In addition, the investigators aim to visualize these changes in the brain because of priming, possibly altered network-organisation.

NCT ID: NCT05100771 Recruiting - Focal Epilepsy Clinical Trials

Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy

ORACLE
Start date: March 14, 2022
Phase:
Study type: Observational

Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.

NCT ID: NCT05081518 Terminated - Focal Epilepsy Clinical Trials

A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy

Start date: September 29, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to investigate effects of Lu AG06466 on seizure activity after increasing daily doses during 4 weeks in participants with an implanted responsive neurostimulation system.

NCT ID: NCT04998123 Not yet recruiting - Seizures Clinical Trials

Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

Start date: January 2025
Phase: N/A
Study type: Interventional

This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.