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

Not Applicable

Not yet recruiting

• Conditions: Drug Resistant Epilepsy
• Interventions: Device: VNS Treatment

• Registration Number: NCT06340802
• Lead Sponsor: Synergia Medical

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.

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 Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-06
• Primary Completion: 2025-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VNS Treatment	VNS Treatment	Vagus nerve stimulation is started 2-week after the implantation.

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	through 3 months of implantation	Incidence rate of NAO.VNS device-related treatment emergent adverse events (TEAE)
Procedure and/or device related adverse events	through 30 days post implant	Incidence of procedure and/or device related adverse events

Secondary Outcome Measures

Name	Time	Method
Device-related treatment emergent adverse events	through 6, 12, 18 & 24 months of implantation	Incidence rate of NAO.VNS device-related treatment emergent adverse events
Procedural Success	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).
Changed in mood	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)
Device deficiencies	at 3, 6, 12, 18 and 24 months of implantation	Number of physician reported device deficiencies related to NAO.VNS
Change in seizure severity	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)
Change in seizure frequency	at 3, 6, 12, 18 & 24 months of implantation.	Change in seizure frequency, as compared to preoperative baseline
Proportion of responders	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
Usability	at 3, 6, 12, 18 & 24 months of implantation	Usability and workflow assessment evaluated through a practitioner's and patient's questionnaire
Change in quality of life	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)

Trial Locations

Locations (3)

Cliniques Universitaires St.-Luc; 🇧🇪 Brussels, Belgium

UZ GENT (Universitair Ziekenhuis Gent); 🇧🇪 Gent, Belgium

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany