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

Drug Resistant Epilepsy Clinical Trial

— AURORA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340802
• Other study ID #: SYG001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Synergia Medical
• Contact: Catherine Léonard, PhD
• Phone: +32473290006
• Email: catherine.leonard[@]synergiam.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Prior treatment of epilepsy with cerebellar or thalamic stimulation.

9. Prior therapeutic brain surgery for epilepsy.

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).

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Device:
• VNS Treatment
Vagus nerve stimulation is started 2-week after the implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synergia Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Treatment emergent adverse events	Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)	through 3 months of implantation
Primary	Procedure and/or device related adverse events	Incidence of procedure and/or device related adverse events	through 30 days post implant
Secondary	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
Secondary	Device deficiencies	Number of physician reported device deficiencies related to NAO.VNS	at 3, 6, 12, 18 and 24 months of implantation
Secondary	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
Secondary	Change in seizure frequency	Change in seizure frequency, as compared to preoperative baseline	at 3, 6, 12, 18 & 24 months of implantation.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Usability	Usability and workflow assessment evaluated through a practitioner's and patient's questionnaire	at 3, 6, 12, 18 & 24 months of implantation