Clinical trial: Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System. (CORE-VNS)

May 18, 2018

Summary: Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

Primary Outcome Measures Include: Seizure Frequency, Maximum Seizure Free Period, Seizure Severity

Study start date: February 5, 2018
Estimated study completion date: March 31, 2027

Eligibility Criteria

Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:

• Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
• Able and willing to comply with the frequency of study visits.
• Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.

Exclusion Criteria:

• There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.