Evaluating a new device for treating drug-resistant epilepsy

A First in HUman Study for Resistant Epilepsy with the Vagus Nerve StimulatiOn Device by SyneRgia MedicAl

This study is testing a new device to see if it can safely help people with epilepsy that doesn't respond to medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Synergia Medical (industry)
• Locations: 3 sites (Brussels and 2 other locations)
• Trial ID: NCT06340802 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm interventional study aims to assess the safety of the NAO.VNS SYSTEM, a vagus nerve stimulation device, in patients with drug-resistant epilepsy. Up to 10 eligible patients will undergo implantation of the device, followed by a titration phase and a 24-month follow-up. The study will be conducted at two sites and will involve careful monitoring of seizure activity through diaries. The primary goal is to ensure the safety of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of drug-resistant epilepsy who are eligible for vagus nerve stimulation.

Not a fit: Patients who do not have drug-resistant epilepsy or those who are not candidates for vagus nerve stimulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with drug-resistant epilepsy.

How similar studies have performed: While vagus nerve stimulation has been previously studied, this specific device and its application in drug-resistant epilepsy represent a novel approach.

Eligibility criteria

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).

Where this trial is running

Brussels and 2 other locations

• Cliniques Universitaires St.-Luc — Brussels, Belgium (RECRUITING)
• UZ GENT (Universitair Ziekenhuis Gent) — Gent, Belgium (RECRUITING)
• Universitätsklinikum Freiburg — Freiburg, Germany (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Catherine Léonard, PhD

Conditions: Drug Resistant Epilepsy, vagus nerve stimulation