Drug Resistant EpilepsyAURORANCT06340802
A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl
A study testing VNS Treatment in people with Drug Resistant Epilepsy, run by Synergia Medical at 2 sites in Belgium.
Trial summary
This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- VNS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesBelgium
- Study dates
- 6 Aug 2024to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques Universitaires St.-Luc
Brussels, 1200
UZ GENT (Universitair Ziekenhuis Gent)
Ghent, 9000
About this study
This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.
Read the 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.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- VNS Treatment
- Keywords
- vagus nerve stimulation
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNS TreatmentDevice
Vagus nerve stimulation is started 2-week after the implantation
| Study group | Role | What they receive |
|---|---|---|
| VNS Treatment | Experimental | Vagus nerve stimulation is started 2-week after the implantation. Receives: Device: VNS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)
Measured: through 3 months of implantation
Procedure and/or device related adverse events
Incidence of procedure and/or device related adverse events
Measured: through 30 days post implant
Secondary outcomes (9)
Device-related treatment emergent adverse events
Incidence rate of NAO.VNS device-related treatment emergent adverse events
Measured: through 6, 12, 18 & 24 months of implantation
Device deficiencies
Number of physician reported device deficiencies related to NAO.VNS
Measured: 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).
Measured: at implantation surgery
Change in seizure frequency
Change in seizure frequency, as compared to preoperative baseline
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 3, 6, 12, 18 & 24 months of implantation
Usability
Usability and workflow assessment evaluated through a practitioner's and patient's questionnaire
Measured: at 3, 6, 12, 18 & 24 months of implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start6 Aug 2024
- Primary completion6 Jan 2025
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synergia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340802
- Sponsor's protocol ID
- SYG001
- Acronym
- AURORA
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl
- ClinicalTrials.gov ID
- NCT06340802
- Acronym / sponsor ID
- AURORA / SYG001
- Conditions
- Drug Resistant Epilepsy
- Keywords
- vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Synergia MedicalIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VNS Treatment | Experimental | Device: VNS TreatmentVagus nerve stimulation is started 2-week after the implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNS TreatmentVagus nerve stimulation is started 2-week after the implantation | Device | VNS Treatment |
Primary outcome
Treatment emergent adverse events
Time frame: through 3 months of implantation
Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)
Procedure and/or device related adverse events
Time frame: through 30 days post implant
Incidence of procedure and/or device related adverse events
9 secondary outcomes
Device-related treatment emergent adverse events
Time frame: through 6, 12, 18 & 24 months of implantation
Device deficiencies
Time frame: at 3, 6, 12, 18 and 24 months of implantation
Procedural Success
Time frame: at implantation surgery
Change in seizure frequency
Time frame: at 3, 6, 12, 18 & 24 months of implantation.
Proportion of responders
Time frame: 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 quality of life
Time frame: at 3, 6, 12, 18 & 24 months of implantation
Changed in mood
Time frame: at 3, 6, 12, 18 & 24 months of implantation
Usability
Time frame: at 3, 6, 12, 18 & 24 months of implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNS Treatment in people with Drug Resistant Epilepsy, run by Synergia Medical at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: through 3 months of implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.