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ACTIVE NOT RECRUITING
NCT04693221
NA

Optimization of the Parameters of Vagal Nerve Stimulation

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2021-04-16

Completion Date

2026-12-12

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

OTHER

Choice of VNS set of parameters based on the lowest PLI

Vagal nerve stimulation according to PLI results.

OTHER

EEG

Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.

Locations (18)

Department of functional explorations of the nervous system, CHU

Amiens, France, France

Neuropediatrics department, CHU Angers

Angers, France, France

Neurology Department, CHU Bordeaux

Bordeaux, France, France

Clinical neurophysiology, CHU Dijon

Dijon, France, France

Epilepsy neurophysiopathology department, CHU Grenoble

Grenoble, France, France

Clinical neurophysiology, CHU Lille

Lille, France, France

HCL Lyon

Lyon, France, France

Department of clinical neurophysiology, Hôpital La Timone, APHM

Marseille, France, France

Neurosurgery Department, CHRU Nancy

Nancy, France, France

Neurosurgery Department, CHU Nantes

Nantes, France, France

Neurosurgery Department, APHP

Paris, France, France

Neurophysiology Department

Paris, France, France

Epileptology Department, CHU Rennes

Rennes, France, France

Neurophysiology Department, CHU Rouen

Rouen, France, France

Neurology Department, CHU Strasbourg

Strasbourg, France, France

Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

Toulouse, France, France

Neurology and clinical neurophysiology, CHU Bretonneau

Tours, France, France

Hôpital St Joseph St Luc

Lyon, FRA, France