PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1

Study Overview
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Brief Summary
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This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

Detailed Description
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In 2005 Cyberonics, Inc. initiated PuLsE: an open, prospective, randomized, parallel group study directly comparing Best Medical Practice with and without adjunctive VNS Therapy. In July 2008, the decision was made to discontinue this study due to lower than expected enrolment, impairing the possibility to meet the primary objective with appropriate statistical power. However, the relatively large number of participants (n=121) randomized in the original PuLsE study offers the possibility to generate scientifically valuable and original findings if additional follow-up data can be gathered. After consultation with the PuLsE Investigators, Cyberonics decided to implement an observational long-term follow-up of the participants enrolled in the original PuLsE study.

Official Title
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A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy

Conditions
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Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the study, the participant must meet all the following criteria: Participant must have been randomized in the original PuLsE study. Participant must have baseline data from the original PuLsE study. Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance. Participant or legal guardian understands study procedures and has voluntarily signed an informed consent for PuLsE 2 in accordance with institutional and local regulatory policies. Exclusion Criteria: The presence of any of the following will exclude a participant from the study: Participant has a history of non-compliance with the completion of a seizure diary. Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. Participant is expected to require full body magnetic resonance imaging during the clinical study.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VNS Therapy<br> | |
| Best Medical Practice<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory evaluations | The objective of this post-market study is to perform exploratory evaluations to identify clinically and statistically significant predictors of response at all follow-up visits in participants with drug-resistant epilepsy with partial-onset seizures treated with Best Medical Practice with or without adjunctive VNS Therapy. This will be accomplished through regression modeling of the response variates (including change in baseline quality of life score and percent reduction in seizure frequency). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice |  | 5 years | 
| Change from baseline at all follow-up visits across all health outcome measurements |  | 5 years | 
| Evaluation of safety and tolerability |  | 5 Years | 
| Evaluation of change from baseline at all follow-up visits of Best Medical Practice with and without adjunctive VNS Therapy on health outcome measurements and quality of life (QOL) |  | 5 Years | 
| Sub-analysis to evaluate the change from baseline on quality of life |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures