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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Device: VNS Treatment

Detailed Description

This is the first clinical investigation with the NAO.VNS SYSTEM from Synergia Medical.

Up to 10 patients with drug resistant epilespy, who are eligible for vagus nerve stimulation, will be included in two sites.

The total duration of the study is expected to be 36 months. Study procedures are composed of (i) baseline, (ii) implantation, (iii) titration and (iv) follow-up until 24 months.

Primary objective is to evaluate safety of the NAO.VNS SYSTEM.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St.-Luc
  • Gent, Belgium, 9000
    • UZ Gent (Universitair Ziekenhuis Gent)
• Germany
  • Freiburg, Germany, D-79106
    • Universitatsklinikum Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VNS Treatment; Vagus nerve stimulation is started 2-week after the implantation.	Device: VNS Treatment; Vagus nerve stimulation is started 2-week after the implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related treatment emergent adverse events	Incidence rate of NAO.VNS device-related treatment emergent adverse events	through 6, 12, 18 & 24 months of implantation
Device deficiencies	Number of physician reported device deficiencies related to NAO.VNS	at 3, 6, 12, 18 and 24 months of implantation
Procedural Success	Procedural Success defined as successful implantation of the device without the occurrence of procedure related serious adverse events (from incision to closure).	at implantation surgery
Change in seizure frequency	Change in seizure frequency, as compared to preoperative baseline	at 3, 6, 12, 18 & 24 months of implantation.
Proportion of responders	Proportion of patients with at least a 50% reduction in the frequency of seizures, as compared to preoperative baseline	at 3, 6, 12, 18 & 24 months of implantation
Change in seizure severity	Change in seizure severity, as compared to preoperative baseline, as measured by the "Seizure Severity Questionnaire" (SSQ)	at 3, 6, 12, 18 & 24 months of implantation
Change in quality of life	Change in quality of life, as compared to preoperative baseline, as measured by the "QUALITY OF LIFE IN EPILEPSY" (QOLIE-31)	at 3, 6, 12, 18 & 24 months of implantation
Changed in mood	Changed in mood, as compared to preoperative baseline, as measured by the "Beck Depression Inventory" (BDI)	at 3, 6, 12, 18 & 24 months of implantation
Usability	Usability and workflow assessment evaluated through a practitioner's and patient's questionnaire	at 3, 6, 12, 18 & 24 months of implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoints	Number of successfull Laryngeal Muscle-Evoked Potential recordings during follow-up visits recorded by the NAO.VNS clinician programmer.	at 3, 6, 12, 18 & 24 months of implantation

Collaborators and Investigators

• Sponsor: Synergia Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: vagus nerve stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: SYG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No