A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl

NCT06340802 | Active Not Recruiting

• 1 other identifier: SYG001
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief Summary

This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.

Conditions

Drug Resistant Epilepsy

Keywords

vagus nerve stimulation

Outcome Measures

Primary Outcomes (2)

• Treatment emergent adverse events

  Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)

  through 3 months of implantation

• Procedure and/or device related adverse events

  Incidence of procedure and/or device related adverse events

  through 30 days post implant

Secondary Outcomes (9)

• Device-related treatment emergent adverse events

  through 6, 12, 18 & 24 months of implantation

• Device deficiencies

  at 3, 6, 12, 18 and 24 months of implantation

• Procedural Success

  at implantation surgery

• Change in seizure frequency

  at 3, 6, 12, 18 & 24 months of implantation.

• Proportion of responders

  at 3, 6, 12, 18 & 24 months of implantation

Other Outcomes (1)

• Exploratory Endpoints

  at 3, 6, 12, 18 & 24 months of implantation

Study Arms (1)

VNS Treatment

EXPERIMENTAL

Vagus nerve stimulation is started 2-week after the implantation.

Device: VNS Treatment

Interventions

VNS Treatment DEVICE

Vagus nerve stimulation is started 2-week after the implantation

VNS Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects diagnosed with Drug Resistant Epilepsy (DRE) and candidate for VNS treatment
• Ability of subjects or, in the case of cognitive impairment, their caregiver, to accurately count seizures and complete seizure diaries.
• Adult subjects, age ≥ 18.
• 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.
• 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.
• Female subjects of childbearing age using acceptable methods of birth control (abstinence considered acceptable).

You may not qualify if:

• Unstable medical condition likely to precipitate seizures and make it difficult to evaluate efficacy.
• Prior cervical vagotomy.
• Progressive neurological disease.
• Pregnancy.
• Significant cardiac or pulmonary disease under treatment.
• History of noncompliance for seizure diary completion.
• Prior implant with vagus nerve stimulation device.
• Current active treatment of epilepsy with cerebellar or thalamic stimulation.
• Prior therapeutic brain surgery for epilepsy within the last 6 months prior to NAO.VNS implantation.
• Receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation.
• Currently receiving another investigational treatment.
• Patient with Vocal Cord Palsy (VCP), including unilateral, whatever the side.
• Diabetic patients and all patients with a known vagal neuropathy.
• Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor) are allowed).
• Patient currently participating in another clinical investigation, without explicit consent of the Sponsor (non-interventional registries are allowed).

Sponsors & Collaborators

• Synergia Medical: lead

Study Sites (3)

Cliniques Universitaires St.-Luc

Brussels, 1200, Belgium

Location

UZ GENT (Universitair Ziekenhuis Gent)

Ghent, 9000, Belgium

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 2, 2024
• Study Start: August 6, 2024
• Primary Completion: January 6, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); BE (2)