Optimization of the Parameters of Vagal Nerve Stimulation

N/AActive Not RecruitingNCT04693221

Assistance Publique Hopitaux De Marseille140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Epilepsy

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Difficulty to read or understand the French language, or inability to understand the information regarding the study * Total patient's IQ below 64 * Subject in exclusion period due to enrolment in another study * Patient with postoperative left vocal cord paralysis * Patient on VNS since more than 6 months

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

...and 8 more locations

Outcomes