Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

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.

Inclusion Criteria:

1. 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.

2. Patients must be 12 years or older and have partial onset seizures or must follow the
indication for use statement for VNS Therapy.

3. 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.

4. 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.

5. Patient must be taking at least 1 anti-epileptic drug treatment

Exclusion Criteria:

1. Patient currently uses, or is expected to use during the study, short-wave diathermy,
microwave diathermy, or therapeutic ultrasound diathermy.

2. Patient is expected to require MRI using a body coil for transmission of RF during the
clinical study.

3. Patient has a progressive neurological condition (e.g. brain tumor etc.).

4. In the investigator's opinion, the patient or legal guardian is unable to comply with
the frequency of clinic visits during the study.

5. Patient is currently using an investigational device or pharmacologic medication not
approved by the FDA.

6. Patient was previously implanted with VNS Therapy.

7. In the investigator's opinion, the patient is considered a suicide risk or is
otherwise not a good candidate for this study.

8. Patient/Caregiver is unable to complete the required study follow-up visits and
assessments.