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ISRCTN
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ISRCTN51185809
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ClinicalTrials.gov identifier
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NCT00522418
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Public title
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Study comparing best medical practice with or without vagus nerve stimulation (VNS) therapy in pharmacoresistant partial epilepsy patients
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Scientific title
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An open Prospective randomised Long-term Effectiveness study, comparing adjunctive vagus nerve stimulation (VNS) therapy with best medical practice in patients with pharmaco-resistant partial epilepsy aged 16 and above
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Acronym
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PuLsE
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Serial number at source
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E-100
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Study hypothesis
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This is an open prospective randomised and comparative long-term effectiveness study, comparing adjunctive vagus nerve stimulation (VNS) therapy with best medical practice in patients with pharmaco-resistant partial epilepsy. The minimum age of enrolment is 16 years.
As of 19/02/2009 this record was updated to include an amendment to the anticipated start date; the initial start dates at the time of registration was:
Initial anticipated start date: 01/09/2005
Please also note that this trial was prematurely discontinued on 28 July 2008 due to recruitment issues.
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Lay summary
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Ethics approval
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Added 19/02/2009: Ethics Committee of "Hôpital Neurologique" in Lyon (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale) gave approval on the 20th December 2005 (ref: A 05-073)
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Study design
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Randomised, multicentre controlled trial
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Countries of recruitment
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Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
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Disease/condition/study domain
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Epilepsy
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Participants - inclusion criteria
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To be eligible for enrolment in the study, patients must meet all of the following criteria:
1. Patient has confirmed partial onset seizures
2. Seizure activity is not adequately controlled by patient's current antiepileptic drug (AED) regimen
3. Patient is age 16 up to age 75, either sex
4. Patient is able to give accurate seizure counts and health outcomes information
5. Patient has previously failed at least 3 AEDs in single or combination use
6. During baseline, patient should take 1 AED
7. Patient should have confirmed epilepsy for a minimum of 2 years
8. Patient's AED regimen is stable for at least one month prior to enrolment
9. Patient has at least one partial onset seizure per month
10. Patients with an intelligence quotient (IQ) greater than or equal to 70
11. Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional policies
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Participants - exclusion criteria
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Patients with any of the following will not be eligible for enrolment:
1. Patient has a history of pseudoseizures
2. Patient has had more than one episode of status epilepticus (SE) in the past 12 months
3. Patient has idiopathic or difficult to classify seizures
4. Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy
5. Patient has had a unilateral or bilateral cervical vagotomy
6. Patient has a history of non-compliance for seizure diary completion
7. Patient has taken an investigational drug within a period of 3 months prior to inclusion
8. Patient is currently using another investigational medical device
9. Patient has a significant cardiac or pulmonary condition currently under treatment
10. Patient has other progressive neurological disease, significant central nervous system (CNS) disease or injury, or cervical fracture that makes implantation of the VNS therapy system difficult
11. Patient has previously undergone brain surgery
12. Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
13. Patient currently lives more than two hours away from the study site or plans to relocate to a location distant from the study site within one year of enrolment in the study
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Anticipated start date
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17/02/2006
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Anticipated end date
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31/12/2009
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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366
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Interventions
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Intervention:
VNS therapy is implanted under the left clavicle and typically this is done in 1 hour. The electrode is tunneled from the device sub-pectoral pocket to the left vagus nerve.
Control:
Best medical practice.
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Primary outcome measure(s)
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1. To show over time that the efficacy of adding VNS therapy is non-inferior to the efficacy obtained with best medical practice
2. To show over time superiority of VNS therapy in health outcomes compared with best medical practice using the 89-item Quality of Life in Epilepsy (QOLIE-89) inventory
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Secondary outcome measure(s)
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To compare the efficacy and health outcomes of both treatment arms using other assessments focused on:
1. Seizure freedom
2. Mood
3. Safety/tolerability
4. Drug changes
5. Retention rate
6. Compliance
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Sources of funding
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Cyberonics Europe SA/NV (Belgium) - educational grant to the academic centre collecting the data
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Trial website
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Publications
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Contact name
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Prof
Philippe
Ryvlin
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Address
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Hôpital Neurologique
Unité d’epileptologie
59 bd Pinel
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City/town
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Lyon
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Zip/Postcode
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69003
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Country
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France
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Sponsor
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Cyberonics Europe SA/NV (Belgium)
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Address
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Belgicastraat 9
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City/town
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Zaventem
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Zip/Postcode
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1930
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Country
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Belgium
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Date applied
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09/02/2005
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Last edited
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19/02/2009
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Date ISRCTN assigned
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18/02/2005
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