Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

  • End date
    Mar 31, 2027
  • participants needed
  • sponsor
Updated on 29 January 2021
Wim Van Grunderbeek
Primary Contact
King Faisal Specialist Hospital & Research Center (0.0 mi away) Contact
+72 other location
vagal nerve stimulation
vagus nerve stimulation
intractable epilepsy


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.

Condition Seizure, Epilepsy, Intractable Epilepsy, Seizure Disorders (Pediatric), Drug Resistant Epilepsy, Seizure Disorders, seizures, fits, fitting, convulsions, epileptic, seizure disorder, epilepsia, epileptics
Treatment Vagus Nerve Stimulation (VNS) Therapy
Clinical Study IdentifierNCT03529045
Last Modified on29 January 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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