Optimization of the Parameters of Vagal Nerve Stimulation (OPSTIMVAG)

February 7, 2026 updated by: Assistance Publique Hopitaux De Marseille

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • FRA
      • Lyon, FRA, France, 69007
        • Hôpital St Joseph St Luc
    • France
      • Amiens, France, France, 80054
        • Department of functional explorations of the nervous system, CHU
      • Angers, France, France, 49933
        • Neuropediatrics department, CHU Angers
      • Bordeaux, France, France, 33000
        • Neurology Department, CHU Bordeaux
      • Dijon, France, France, 21079
        • Clinical neurophysiology, CHU Dijon
      • Grenoble, France, France, 38043
        • Epilepsy neurophysiopathology department, CHU Grenoble
      • Lille, France, France, 59037
        • Clinical neurophysiology, CHU Lille
      • Lyon, France, France, 69003
        • HCL Lyon
      • Marseille, France, France, 13885
        • Department of clinical neurophysiology, Hôpital La Timone, APHM
      • Nancy, France, France, 54000
        • Neurosurgery Department, CHRU Nancy
      • Nantes, France, France, 44093
        • Neurosurgery Department, CHU Nantes
      • Paris, France, France, 75013
        • Neurosurgery Department, APHP
      • Paris, France, France, 75014
        • Neurophysiology Department
      • Rennes, France, France, 35000
        • Epileptology Department, CHU Rennes
      • Rouen, France, France, 76000
        • Neurophysiology Department, CHU Rouen
      • Strasbourg, France, France, 67098
        • Neurology Department, CHU Strasbourg
      • Toulouse, France, France, 31059
        • Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan
      • Tours, France, France, 37044
        • Neurology and clinical neurophysiology, CHU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
VNS therapy with randomly-set combination of parameters (similar to current practice)
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.
Experimental: Experimental
VNS therapy with set combination of parameters chosen based on the lowest phase lag index
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.
Other: Choice of VNS set of parameters based on the lowest PLI
Vagal nerve stimulation according to PLI results.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean number of seizures per month
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Mean number of seizures per month
Time Frame: Change from baseline to 12 months
Change from baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score of depression
Time Frame: Change from baseline to 12 months
NDDI-E
Change from baseline to 12 months
Score of anxiety
Time Frame: Change from baseline to 12 months
GAD-7
Change from baseline to 12 months
Number of responders in each group
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Number of responders in each group
Time Frame: Change from baseline to 12 months
Change from baseline to 12 months
Number of generalized seizures
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Number of generalized seizures
Time Frame: Change from baseline to 12 months
Change from baseline to 12 months
Number of seizures with falls
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Number of seizures with falls
Time Frame: Change from baseline to 12 months
Change from baseline to 12 months
Number of seizures with alteration of consciousness
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Number of seizures with alteration of consciousness
Time Frame: Change from baseline to 12 months
Change from baseline to 12 months
Score of depression
Time Frame: Change from baseline to 6 months
NDDI-E
Change from baseline to 6 months
Score of anxiety
Time Frame: Change from baseline to 6 months
GAD-7
Change from baseline to 6 months
Score of quality of life
Time Frame: Change from baseline to 6 months
QUOLIE 31
Change from baseline to 6 months
Score of quality of life
Time Frame: Change from baseline to 12 months
QUOLIE 31
Change from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: jean-olivier ARNAUD, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-05
  • 2020-A02657-32 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on EEG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings