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Clinical Trials in France / NCT04693221
Active, not recruiting Not applicable

Optimization of the Parameters of Vagal Nerve Stimulation

NCT04693221 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique Hopitaux De Marseille
Phase
Not applicable
Started
2021-04-16
Last updated
2026-02-10

Condition(s) studied

Epilepsy

Investigational drug(s) / intervention(s)

Choice of VNS set of parameters based on the lowest PLIEEG

Choice of VNS set of parameters based on the lowest PLI: Vagal nerve stimulation according to PLI results.

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.

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean number of seizures per month — Change from baseline to 6 months
  • Mean number of seizures per month — Change from baseline to 12 months

Trial sites (18)

FacilityCityRegionStatus
Department of functional explorations of the nervous system, CHU Amiens France
Neuropediatrics department, CHU Angers Angers France
Neurology Department, CHU Bordeaux Bordeaux France
Clinical neurophysiology, CHU Dijon Dijon France
Epilepsy neurophysiopathology department, CHU Grenoble Grenoble France
Clinical neurophysiology, CHU Lille Lille France
HCL Lyon Lyon France
Department of clinical neurophysiology, Hôpital La Timone, APHM Marseille France
Neurosurgery Department, CHRU Nancy Nancy France
Neurosurgery Department, CHU Nantes Nantes France
Neurosurgery Department, APHP Paris France
Neurophysiology Department Paris France
Epileptology Department, CHU Rennes Rennes France
Neurophysiology Department, CHU Rouen Rouen France
Neurology Department, CHU Strasbourg Strasbourg France
Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan Toulouse France
Neurology and clinical neurophysiology, CHU Bretonneau Tours France
Hôpital St Joseph St Luc Lyon FRA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04693221 on ClinicalTrials.gov ↗ ← All trials in France