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

Completed

• Conditions: Epilepsy

• Registration Number: NCT01281280
• Lead Sponsor: Cyberonics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-03
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploratory evaluations	5 years	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).

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (18)

CHU Grenoble; 🇫🇷 Grenoble, France

ULB Hopital Erasme; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Hopital Roger Salengro Service de Neurologie; 🇫🇷 Lille Cedex, France

Hopital Notre Dame; 🇨🇦 Montreal, Canada

QE2 Health Sciences Centre Department of Neurology; 🇨🇦 Halifax, Canada

Hopital Neurologique Unite d' epileptologie; 🇫🇷 Lyon, France

Azienda Ospedaliero Universitaria; 🇮🇹 Ancona, Italy

Hopital Gui De Chauliac; 🇫🇷 Montpellier, France

Universitatskliniken Bonn; 🇩🇪 Bonn, Germany

Universitatsklinl Erlangen Zentrum fur Epilepsie; 🇩🇪 Erlangen, Germany

Universita di Bologna; 🇮🇹 Bologna, Italy

Universita di Pisa; 🇮🇹 Pisa, Italy

Azienda Ospedialiera "Bianchi Melacrino Morelli"; 🇮🇹 Reggio Calabria, Italy

Unisersita Cattolica Del Sacro Cuore; 🇮🇹 Rome, Italy

The National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom

Centro Epilessia; 🇮🇹 Torino, Italy

Hans Berger kliniek Neurology; 🇳🇱 Oosterhout, Netherlands