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Optimization of the Parameters of Vagal Nerve Stimulation

NCT04693221 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-10

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Jean-Olivier ARNAUD · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2025-06-13
Completion
2026-12-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693221 on ClinicalTrials.gov