Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

Study Overview
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Brief Summary
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Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.

Detailed Description
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Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.

Official Title
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ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

Conditions
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Epilepsy, Seizures

Intervention / Treatment
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* Device: Vagus Nerve Stimulation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study. Patients must be 12 years or older and have partial onset seizures or must follow the indication for use statement for VNS Therapy. Patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local IRB requirements. Patient must be taking at least 1 anti-epileptic drug treatment Exclusion Criteria: Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. Patient is expected to require MRI using a body coil for transmission of RF during the clinical study. Patient has a progressive neurological condition (e.g. brain tumor etc.). In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study. Patient is currently using an investigational device or pharmacologic medication not approved by the FDA. Patient was previously implanted with VNS Therapy. In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study. Patient/Caregiver is unable to complete the required study follow-up visits and assessments.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Vagus Nerve Stimulation Therapy Standard Titration | Device: Vagus Nerve Stimulation Therapy<br>* Stimulation of the left tenth cranial nerve via VNS Therapy<br>* Other names: VNS Therapy;|
| Group B<br>Vagus Nerve Stimulation Therapy Alternate Titration 1 | Device: Vagus Nerve Stimulation Therapy<br>* Stimulation of the left tenth cranial nerve via VNS Therapy<br>* Other names: VNS Therapy;|
| Group C<br>Vagus Nerve Stimulation Therapy Alternate Titration 2 | Device: Vagus Nerve Stimulation Therapy<br>* Stimulation of the left tenth cranial nerve via VNS Therapy<br>* Other names: VNS Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Patients Reaching the Defined Target Dose | Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame | 12 weeks post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagus Nerve Stimulation, ASCEND, VNS Titration to Improve Tolerance and Accelerate Adaptation