This trial is active, not recruiting.

Condition epilepsy
Sponsor Cyberonics, Inc.
Start date March 2011
End date October 2013
Trial size 81 participants
Trial identifier NCT01281280, E-101 PuLsE 2, Epilepsy (E)-101


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Exploratory evaluations
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

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title 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
Principal investigator Philippe Ryvlin, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Cyberonics, Inc..