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Brain Wave-Guided nerve stimulation may tame Drug-Resistant epilepsy

NCT ID NCT04693221

Disease control Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether fine-tuning a vagal nerve stimulator (VNS) using a brain wave measure called phase lag index (PLI) can better reduce seizures in people with epilepsy that doesn't respond to medication. About 140 participants who already have a VNS device will have their settings chosen either by the PLI method or randomly. The goal is to see if the PLI-guided settings lead to fewer seizures per month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vagal nerve stimulation (VNS) device
What this could lead to
If successful, this could provide a more effective way to set VNS devices, helping more patients with drug-resistant epilepsy have fewer seizures.
What could go wrong
This is a mid-stage study with 140 participants, and the approach is still experimental. It may not work better than standard settings, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy

Contacts and locations

Locations

  • Clinical neurophysiology, CHU Dijon

    Dijon, France, 21079, France

  • Clinical neurophysiology, CHU Lille

    Lille, France, 59037, France

  • Department of clinical neurophysiology, Hôpital La Timone, APHM

    Marseille, France, 13885, France

  • Department of functional explorations of the nervous system, CHU

    Amiens, France, 80054, France

  • Epilepsy neurophysiopathology department, CHU Grenoble

    Grenoble, France, 38043, France

  • Epileptology Department, CHU Rennes

    Rennes, France, 35000, France

  • HCL Lyon

    Lyon, France, 69003, France

  • Hôpital St Joseph St Luc

    Lyon, FRA, 69007, France

  • Neurology Department, CHU Bordeaux

    Bordeaux, France, 33000, France

  • Neurology Department, CHU Strasbourg

    Strasbourg, France, 67098, France

  • Neurology and clinical neurophysiology, CHU Bretonneau

    Tours, France, 37044, France

  • Neuropediatrics department, CHU Angers

    Angers, France, 49933, France

  • Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

    Toulouse, France, 31059, France

  • Neurophysiology Department

    Paris, France, 75014, France

  • Neurophysiology Department, CHU Rouen

    Rouen, France, 76000, France

  • Neurosurgery Department, APHP

    Paris, France, 75013, France

  • Neurosurgery Department, CHRU Nancy

    Nancy, France, 54000, France

  • Neurosurgery Department, CHU Nantes

    Nantes, France, 44093, France

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