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

June 24, 2025 updated by: Synergia Medical
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events
Time Frame: through 3 months of implantation
Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)
through 3 months of implantation
Procedure and/or device related adverse events
Time Frame: through 30 days post implant
Incidence of procedure and/or device related adverse events
through 30 days post implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device-related treatment emergent adverse events
Time Frame: through 6, 12, 18 & 24 months of implantation
Incidence rate of NAO.VNS device-related treatment emergent adverse events
through 6, 12, 18 & 24 months of implantation
Device deficiencies
Time Frame: at 3, 6, 12, 18 and 24 months of implantation
Number of physician reported device deficiencies related to NAO.VNS
at 3, 6, 12, 18 and 24 months of implantation
Procedural Success
Time Frame: at implantation surgery
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
Time Frame: at 3, 6, 12, 18 & 24 months of implantation.
Change in seizure frequency, as compared to preoperative baseline
at 3, 6, 12, 18 & 24 months of implantation.
Proportion of responders
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Endpoints
Time Frame: at 3, 6, 12, 18 & 24 months of implantation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synergia Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Resistant Epilepsy

Clinical Trials on VNS Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings