PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1
NCT ID: NCT01281280
Last Updated: 2014-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2011-03-31
2014-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VNS Therapy
No interventions assigned to this group
Best Medical Practice
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
16 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Ryvlin, MD
Role: PRINCIPAL_INVESTIGATOR
Unité d'épileptologie
Locations
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ULB Hopital Erasme
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
QE2 Health Sciences Centre Department of Neurology
Halifax, , Canada
Hopital Notre Dame
Montreal, , Canada
CHU Grenoble
Grenoble, , France
Hopital Roger Salengro Service de Neurologie
Lille, , France
Hopital Neurologique Unite d' epileptologie
Lyon, , France
Hopital Gui De Chauliac
Montpellier, , France
Universitatskliniken Bonn
Bonn, , Germany
Universitatsklinl Erlangen Zentrum fur Epilepsie
Erlangen, , Germany
Azienda Ospedaliero Universitaria
Ancona, , Italy
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
Centro Epilessia
Torino, , Italy
Hans Berger kliniek Neurology
Oosterhout, , Netherlands
The National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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Other Identifiers
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E-101 PuLsE 2
Identifier Type: OTHER
Identifier Source: secondary_id
Epilepsy (E)-101
Identifier Type: -
Identifier Source: org_study_id
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