Can a new implant tame seizures when drugs fail?
NCT ID NCT06340802
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
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5 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Aug 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cliniques Universitaires St.-Luc
Brussels, 1200, Belgium
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UZ GENT (Universitair Ziekenhuis Gent)
Ghent, 9000, Belgium
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Universitätsklinikum Freiburg
Freiburg im Breisgau, D-79106, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Glowing dye could help surgeons spot hidden epilepsy lesions
- Brain scans may replace invasive electrodes for epilepsy surgery planning