Clinical trial NCT06340802: A First in HUman Study for Resistant Epilepsy with the Vagus Nerve StimulatiOn Device by SyneRgia MedicAl
Official title: A First in HUman Study for Resistant Epilepsy with the Vagus Nerve StimulatiOn Device by SyneRgia MedicAl
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: vagus nerve stimulation
Lead sponsor: Synergia Medical
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: through 3 months of implantation
measure: Procedure and/or device related adverse events
timeFrame: through 30 days post implant
Secondary outcomes:
measure: Device-related treatment emergent adverse events
timeFrame: through 6, 12, 18 & 24 months of implantation
measure: Device deficiencies
timeFrame: at 3, 6, 12, 18 and 24 months of implantation
measure: Procedural Success
timeFrame: at implantation surgery
measure: Change in seizure frequency
timeFrame: at 3, 6, 12, 18 & 24 months of implantation.
measure: Proportion of responders
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
measure: Change in seizure severity
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
measure: Change in quality of life
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
measure: Changed in mood
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
measure: Usability
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
Other outcomes:
measure: Exploratory Endpoints
timeFrame: at 3, 6, 12, 18 & 24 months of implantation
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St.-Luc
city: Gent
country: Belgium
facility: UZ GENT (Universitair Ziekenhuis Gent)
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
Study officials:
References: