Optimizing Vagal Nerve Stimulation Parameters for Epilepsy

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.

This study is testing if adjusting the settings on a vagal nerve stimulation device based on individual brain activity can help people with hard-to-treat epilepsy have fewer seizures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 18 sites (Lyon, FRA and 17 other locations)
• Trial ID: NCT04693221 on ClinicalTrials.gov

What this trial studies

This study aims to improve the effectiveness of vagal nerve stimulation (VNS) in patients with refractory epilepsy by optimizing the stimulation parameters based on individual brain activity measured through scalp EEG. Specifically, it will test whether setting VNS parameters according to the lowest values of the Phase Lag Index (PLI), a marker of brain connectivity, can increase the response rate to VNS compared to standard parameter settings. The study will involve patients who have recently had a VNS device implanted and are experiencing uncontrolled seizures. By tailoring the stimulation settings to each patient's unique brain activity, the researchers hope to enhance treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include male or female patients over 12 years old with pharmaco-resistant epilepsy who have recently received a VNS device.

Not a fit: Patients who have been on VNS for more than 6 months or those with certain postoperative complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve seizure control in patients with refractory epilepsy who are currently limited by ineffective treatments.

How similar studies have performed: While vagal nerve stimulation has been used in epilepsy treatment, this specific approach of optimizing stimulation parameters based on EEG metrics is novel and has not been extensively tested in previous studies.

Eligibility criteria

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

Where this trial is running

Lyon, FRA and 17 other locations

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

Study contacts

• Study coordinator: Romain Carron

Conditions Epilepsy; epilepsy; vagal nerve stimulation; phase lag index