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NCT Number: NCT01281280

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ULB Hopital Erasme, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Exploratory evaluations

    Time frame: 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 outcomes

  1. 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

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

    Time frame: 5 years

  3. Evaluation of safety and tolerability

    Time frame: 5 Years

  4. 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

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

    Time frame: 5 Years

Sponsors and collaborators

Lead sponsor

Cyberonics, Inc.

Industry

Registry information

Official study 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

Acronym: PuLsE 2

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 21, 2011
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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