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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • ULB Hopital Erasme
  • Gent, Belgium
    • UZ Gent
• Canada
  • Halifax, Canada
    • QE2 Health Sciences Centre Department of Neurology
  • Montreal, Canada
    • Hopital Notre Dame
• France
  • Grenoble, France
    • CHU Grenoble
  • Lille Cedex, France
    • Hopital Roger Salengro Service de Neurologie
  • Lyon, France
    • Hopital Neurologique Unite d' epileptologie
  • Montpellier, France
    • Hôpital Gui de Chauliac
• Germany
  • Bonn, Germany
    • Universitatskliniken Bonn
  • Erlangen, Germany
    • Universitatsklinl Erlangen Zentrum fur Epilepsie
• Italy
  • Ancona, Italy
    • Azienda Ospedaliero Universitaria
  • Bologna, Italy
    • Universita di Bologna
  • Pisa, Italy
    • Universita di Pisa
  • Reggio Calabria, Italy
    • Azienda Ospedialiera "Bianchi Melacrino Morelli"
  • Rome, Italy
    • Unisersita Cattolica Del Sacro Cuore
  • Torino, Italy
    • Centro Epilessia
• Netherlands
  • Oosterhout, Netherlands
    • Hans Berger kliniek Neurology
• United Kingdom
  • London, United Kingdom
    • The National Hospital for Neurology and Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of participants previously enrolled in the original PuLsE study diagnosed with drug-resistant epilepsy with partial-onset seizures. All patients will be analyzed according to the treatment that they have actually received and followed in this new study regardless of what treatment groups they were randomized in the previous study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VNS Therapy
Best Medical Practice

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Cyberonics, Inc.
• Investigators: Principal Investigator: Philippe Ryvlin, MD, Unité d'épileptologie

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: PuLsE 2, Drug-resistant Epilepsy Partial-onset Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: Epilepsy (E)-101; E-101 PuLsE 2 (Other Identifier: Cyberonics)