Can a new implant tame seizures when drugs fail?

NCT ID NCT06340802

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests the safety of a new device called the NAO.VNS System for people with drug-resistant epilepsy, a condition where seizures continue despite medication. The device is implanted and delivers vagus nerve stimulation, which may help reduce seizure activity. Researchers will monitor participants for side effects and device-related problems. The study is small and early, focusing on whether the device is safe to use.

What this could mean

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

Active substance
NAO.VNS System, a vagus nerve stimulation device implanted to reduce seizures
What this could lead to
If the device proves safe, it could offer a new option for people with epilepsy whose seizures do not respond to medication.
What could go wrong
This is a very early, small study focused on safety, not effectiveness. The device may cause side effects or fail to reduce seizures.

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

5 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: 1. Ability to understand the Informed Consent Form (ICF) and the study procedures and provide written consent or, in case of cognitive impairment, be the legal ward of a person who is able and willing to provide written consent. 2. Subjects diagnosed with Drug Resistant Epilepsy (DRE) and candidate for VNS treatment 3. Ability of subjects or, in the case of cognitive impairment, their caregiver, to accurately count seizures and complete seizure diaries. 4. Adult subjects, age ≥ 18. 5. Willingness of subjects or, in the case of cognitive impairment, their caregiver, to charge the NAO.VNS system with the Smart Charger on a weekly basis. 6. Subjects' willingness to follow the protocol procedures. For example, subject should have a careful seizure diary completion according to standard of care to ensure 8 weeks of data available by time of implant. 7. Female subjects of childbearing age using acceptable methods of birth control (abstinence considered acceptable). Exclusion Criteria: 1. Unstable medical condition likely to precipitate seizures and make it difficult to evaluate efficacy. 2. Prior cervical vagotomy. 3. Progressive neurological disease. 4. Pregnancy. 5. Significant cardiac or pulmonary disease under treatment. 6. History of noncompliance for seizure diary completion. 7. Prior implant with vagus nerve stimulation device. 8. Current active treatment of epilepsy with cerebellar or thalamic stimulation. 9. Prior therapeutic brain surgery for epilepsy within the last 6 months prior to NAO.VNS implantation. 10. Receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation. 11. Currently receiving another investigational treatment. 12. Patient with Vocal Cord Palsy (VCP), including unilateral, whatever the side. 13. Diabetic patients and all patients with a known vagal neuropathy. 14. Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor) are allowed). 15. Patient currently participating in another clinical investigation, without explicit consent of the Sponsor (non-interventional registries are allowed).

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cliniques Universitaires St.-Luc

    Brussels, 1200, Belgium

  • UZ GENT (Universitair Ziekenhuis Gent)

    Ghent, 9000, Belgium

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, D-79106, Germany

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