Condition category
Nervous System Diseases
Date applied
09/02/2005
Date assigned
18/02/2005
Last edited
22/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philippe Ryvlin

ORCID ID

Contact details

Hôpital Neurologique
Unité d’epileptologie
59 bd Pinel
Lyon
69003
France

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

Sponsor information

Organisation

Cyberonics Europe SA/NV (Belgium)

Sponsor details

Belgicastraat 9
Zaventem
1930
Belgium

Sponsor type

Industry

Website

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

Publication citations

Additional files

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.