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

Cyberonics, Inc.81 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Epilepsy

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be eligible for the study, the participant must meet all the following criteria: 1. Participant must have been randomized in the original PuLsE study. 2. Participant must have baseline data from the original PuLsE study. 3. Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance. 4. 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: 1. Participant has a history of non-compliance with the completion of a seizure diary. 2. Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. 3. Participant is expected to require full body magnetic resonance imaging during the clinical study.

Locations (18)

ULB Hopital Erasme

Brussels, Belgium

UZ Gent

Ghent, Belgium

QE2 Health Sciences Centre Department of Neurology

Outcomes

Primary Outcomes

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).

Time frame: 5 years

Secondary Outcomes

Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice

Time frame: 5 years

Change from baseline at all follow-up visits across all health outcome measurements

Time frame: 5 years

Evaluation of safety and tolerability

Time frame: 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)

Time frame: 5 Years

Sub-analysis to evaluate the change from baseline on quality of life

Time frame: 5 Years

Data from ClinicalTrials.gov

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