PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1 (PuLsE 2)
14. oktober 2014 opdateret af: Cyberonics, Inc.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
81
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussels, Belgien
- ULB Hôpital Erasme
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Gent, Belgien
- UZ Gent
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Halifax, Canada
- QE2 Health Sciences Centre Department of Neurology
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Montreal, Canada
- Hopital Notre Dame
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London, Det Forenede Kongerige
- The National Hospital for Neurology and Neurosurgery
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Grenoble, Frankrig
- CHU Grenoble
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Lille Cedex, Frankrig
- Hopital Roger Salengro Service de Neurologie
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Lyon, Frankrig
- Hopital Neurologique Unite d' epileptologie
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Montpellier, Frankrig
- Hôpital Gui de Chauliac
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Oosterhout, Holland
- Hans Berger kliniek Neurology
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Ancona, Italien
- Azienda Ospedaliero Universitaria
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Bologna, Italien
- Universita di Bologna
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Pisa, Italien
- Universita di Pisa
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Reggio Calabria, Italien
- Azienda Ospedialiera "Bianchi Melacrino Morelli"
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Rome, Italien
- Unisersita Cattolica Del Sacro Cuore
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Torino, Italien
- Centro Epilessia
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Bonn, Tyskland
- Universitatskliniken Bonn
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Erlangen, Tyskland
- Universitatsklinl Erlangen Zentrum fur Epilepsie
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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VNS Therapy
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Best Medical Practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Exploratory evaluations
Tidsramme: 5 years
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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).
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5 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice
Tidsramme: 5 years
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5 years
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Change from baseline at all follow-up visits across all health outcome measurements
Tidsramme: 5 years
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5 years
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Evaluation of safety and tolerability
Tidsramme: 5 Years
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5 Years
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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)
Tidsramme: 5 Years
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5 Years
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Sub-analysis to evaluate the change from baseline on quality of life
Tidsramme: 5 Years
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5 Years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Philippe Ryvlin, MD, Unité d'épileptologie
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2011
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
19. januar 2011
Først indsendt, der opfyldte QC-kriterier
20. januar 2011
Først opslået (Skøn)
21. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Epilepsy (E)-101
- E-101 PuLsE 2 (Anden identifikator: Cyberonics)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Epilepsi
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Boston Children's HospitalRekrutteringEpilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdomForenede Stater