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Drug Resistant Epilepsy clinical trials

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NCT ID: NCT04935567 Not yet recruiting - Clinical trials for Drug Resistant Epilepsy

PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy

PRECISE
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy who are not eligible for resective epilepsy surgery with responders rates about 50% (≥50% seizure reduction). At the moment, there is not a widely-accepted possibility to predict VNS efficacy in a given patient based on pre-implantation data, which can lead to unnecessary surgery and improper allocation of financial resources. The principal aim of PRECISE (PRediction of vagal nerve stimulation EfficaCcy In drug-reSistant Epilepsy) study is to verify the predictability of VNS efficacy by analysis of pre-implantation routine EEG. The PRECISE relies on the results of our previous work, which developed a statistical classifier for VNS response (responders vs. non-responders) based on differences in EEG power spectra dynamics (Pre-X-Stim). PRECISE is designed as a prospective multicentre study in which patients indicated to VNS therapy will be recruited. Patients will be classified as predicted responders vs. predicted non-responders using pre-implantation EEG analyses. After the first and the second year of the study, the real-life outcome (responder vs. non-responder) will be determined. The real-life outcome and predicted outcome will be compared in terms of accuracy, specificity, and sensitivity. In the meantime, the patients will be managed according to the best clinical practice to obtain the best therapeutical response.

NCT ID: NCT04601974 Not yet recruiting - Clinical trials for Drug Resistant Epilepsy

Lentiviral Gene Therapy for Epilepsy

Start date: September 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/IIa clinical trial investigating the safety of a lentiviral epilepsy gene therapy using an engineered potassium channel in patients with refractory epilepsy.

NCT ID: NCT04553354 Not yet recruiting - Clinical trials for Drug Resistant Epilepsy

Cortical Resections in Drug Resistant Epilepsy

Start date: September 10, 2020
Phase:
Study type: Observational

The aim of the study is to evaluate safety and efficacy of epilepsy surgery in the form of cortical resections in patients with refractory epilepsy and to review outcomes of resection procedures in focal epilepsy.

NCT ID: NCT04542629 Not yet recruiting - Refractory Epilepsy Clinical Trials

Comparative Study of Dietary and Immunological Management of Refractory Epilepsy in Children

Start date: October 1, 2020
Phase: Phase 4
Study type: Interventional

1. Comparison of the efficacy of Rituximab and ketogenic diet in controlling refractory seizures versus the traditional lines as corticosteroid and trace elements. 2. Improving the management of children with refractory seizures

NCT ID: NCT03741192 Not yet recruiting - Clinical trials for Epilepsy Intractable

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Start date: January 2020
Phase: N/A
Study type: Interventional

This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.

NCT ID: NCT03475225 Not yet recruiting - Clinical trials for Drug Resistant Epilepsy

Vitamine D in Drug Resistant Epilepsy

EPI-D
Start date: April 2018
Phase: Phase 3
Study type: Interventional

Almost all patients with epilepsy living in the region of Paris have vitamin D deficiency, which is severe in 1/3 of the cases. The impact of this deficiency on epilepsy is unknown, despite the suggested benefits of vitamin D therapy including better seizure control and improvement of comorbidities (fatigue, anxiety, depression) in drug-resistant patients. Recommendations for vitamin D supplementation based on the serum level in the general population cannot be applied to patients with epilepsy due to interference of antiepileptic drugs in the vitamin D metabolism. Animal models, mechanisms of action studies and ecological information provide objective data for a direct antiepileptic effect of vitamin D. Human studies seem to confirm the antiepileptic effect of vitamin D but there are no controlled studies on large populations. The investigators aim to assess prospectively the effect of the treatment of vitamin D deficiency providing a high level of evidence. The investigators propose a multicentre placebo controlled randomized double-blind study, testing vitamin D supplementation against placebo in 400 drug-resistant patients to assess the short-term (3 months) and long-term (1 year) benefits on epilepsy. The investigators hypothesize that the treatment of vitamin D deficiency will result in significant reduction of seizure frequency, and improvement of comorbid symptoms as well as quality of life. The impact on the care of patients is important because better epilepsy control allows reduction of the antiepileptic drugs and side effects. This again is a key for the recovery of social and professional activities, and reduction of costs related to the disease.