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.
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Male or female epileptic patients over 12 years of age
• Suffering from pharmaco-resistant epilepsy
• With newly implanted VNS Aspire SR device
• Surgery performed in the previous 6 months
• Electrode impedance should be within normal range ( \< 4000 Ohms)
• Auto-stim mode working properly
• Mean number of seizures of at least (average 4 (mean value) / months during the baseline period)
• Patient, parents or legally representatives who have given written informed consent to allow the study data collection and procedures
Locations
Other Locations
France
Department of functional explorations of the nervous system, CHU