Epilepsy Clinical Trial
Official title:
Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.
Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.
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