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Completed

NCT Number: NCT03529045

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

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Queensland Children's hospital, Brisbane, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagus Nerve Stimulation (VNS) Therapy

Device

The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.

Primary outcomes

  1. Seizure Frequency

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The average seizure frequency per month over the last 3 months (by type) will be collected

  2. Maximum Seizure Free Period

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The maximum seizure free period over the last 3 months will be collected

  3. Seizure Severity

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe

  4. Post-ictal Severity

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe

  5. Change in Quality of Life

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse

  6. Quality of Sleep

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old

  7. Anti-epileptic Drug Use

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The name and dose of anti-epileptic drugs used will be collected on a case report form

  8. Rescue Drug Use

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The number of times a rescue drug was used will be collected

  9. Seizure Related Emergency Department Visits

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The number of times a patient had a seizure related emergency department (ED) visit will be collected

  10. Seizure Related Hospitalizations

    Time frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable

    The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Official study title

CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy

Acronym: CORE-VNS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 18, 2018
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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