Study comparing best medical practice with or without vagus nerve stimulation (VNS) therapy in pharmacoresistant partial epilepsy patients
| ISRCTN | ISRCTN51185809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51185809 |
| ClinicalTrials.gov number | NCT00522418 |
| Secondary identifying numbers | E-100 |
- Submission date
- 09/02/2005
- Registration date
- 18/02/2005
- Last edited
- 22/03/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philippe Ryvlin
Scientific
Scientific
Hôpital Neurologique
Unité depileptologie
59 bd Pinel
Lyon
69003
France
Study information
| Study design | Randomised multicentre controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | PuLsE |
| Study objectives | 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(s) | Ethics Committee of "Hôpital Neurologique" in Lyon (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale), 20/12/2005, ref: A 05-073 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 17/02/2006 |
| Completion date | 31/12/2009 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 366 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/02/2006 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Belgium
- Canada
- France
- Germany
- Italy
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
Study participating centre
Hôpital Neurologique
Lyon
69003
France
69003
France
Sponsor information
Cyberonics Europe SA/NV (Belgium)
Industry
Industry
Belgicastraat 9
Zaventem
1930
Belgium
Funders
Funder type
Industry
Cyberonics Europe SA/NV (Belgium) - educational grant to the academic centre collecting the data
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |
Editorial Notes
22/03/2016: added link to results - basic reporting.
As of 19/02/2009 this record was updated to include an amendment to the overall trial start date; the initial start date at the time of registration was 01/09/2005.
Please also note that this trial was prematurely discontinued on 28/07/2008 due to recruitment issues.
