Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00522418
Protocol/serial number
E-100
Study information
Scientific title
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
Acronym
PuLsE
Study hypothesis
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.
Ethics approval
Ethics Committee of "Hôpital Neurologique" in Lyon (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale), 20/12/2005, ref: A 05-073
Study design
Randomised multicentre controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Epilepsy
Intervention
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.
Intervention type
Device
Phase
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
17/02/2006
Overall trial end date
31/12/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
366
Participant exclusion criteria
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
Recruitment start date
17/02/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Trial participating centre
Hôpital Neurologique
Lyon
69003
France
Funders
Funder type
Industry
Funder name
Cyberonics Europe SA/NV (Belgium) - educational grant to the academic centre collecting the data
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00522418
Publication summary