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

N/ACompletedNCT03529045

LivaNova827 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

827

Conditions

Epilepsy Seizures Drug Resistant Epilepsy

Interventions

Vagus Nerve Stimulation (VNS) TherapyDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (62)

Outcomes

Primary Outcomes

Seizure Frequency

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

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

Maximum Seizure Free Period

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

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

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

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

Post-ictal Severity

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

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

Change in Quality of Life

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

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

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

Data from ClinicalTrials.gov

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NCT03529045 - Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System. | Crick | Crick