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French Vagus Nerve stimulation (VNS) Epilepsy Registry
ISRCTN ISRCTN72921325
DOI 10.1186/ISRCTN72921325
ClinicalTrials.gov identifier
EudraCT number
Public title French Vagus Nerve stimulation (VNS) Epilepsy Registry
Scientific title A post-market, long-term, prospective, observational, multi-site outcome study to assess the clinical course and seizure reduction of patients treated with adjunctive VNS Therapy in France
Acronym E-104
Serial number at source E-104
Study hypothesis This post-market observational study is designed to assess clinical course and outcome for patients diagnosed with partial or generalized seizures that are refractory to antiepileptic medications treated with standard of care including adjunctive VNS Therapy. Seizure frequency, seizure severity, quality of life, health status and safety will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of the VNS Therapy for patients with epilepsy. The data being collected is not for the purposes of confirmatory assessment.
Lay summary Background and study aims
Vagus Nerve stimulation (VNS) Therapy has been CE marked for the treatment of epilepsy since 1994. This study is designed to assess clinical course and outcomes for patients diagnosed with partial or generalized seizures that are refractory (do not respond) to antiepileptic medication treated with standard of care including adjunctive VNS Therapy for patient with epilepsy.

Who can participate?
All patients who agree to be treated by VNS Therapy should take part to the study except if the patient declines participation.

What does the study involve?
If a patient agree to take part, he/she will be follow for approximately 27 months (2 visits pre-implant & 4 visits post-implantation at 6, 12, 18 and 24 months). During the study, the following items will be assessed: Seizure frequency, seizure severity, quality of life, health status and safety.

What are the possible benefits and risks of participating?
Patient may benefit from more frequent visits with their treating physician.
There are no additional risks for patients in this study other than the loss of confidentiality and those risks associated with receiving a VNS Therapy device.

Where is the study run from?
The study will take place in 15 preselected hospitals across France.

When is the study starting and how long is it expected to run for?
The study started in January 2013 and study is expected to end by 2017.

Who is funding the study?
Cyberonics Europe BVBA

Who is the main contact?
Mr. Mark Bunker, Cyberonics Inc.
Clinical Department
+32 2 720 95 93
Ethics approval Ethics Board : CPP île de France 3, Approval Date : 05 December 2012, Reference: SC2995
Study design Post-market long-term prospective observational multi-site study
Countries of recruitment France
Disease/condition/study domain Drug Resistant Epilepsy
Participants - inclusion criteria 1. All newly patients implanted with a VNS device
2. Patients must have received the information letter and agreed that their data will be collected and transmitted to Cyberonics for analysis
Participants - exclusion criteria Does not inclusion criteria meet
The investigator should refer to the instructions for VNS Therapy use
Anticipated start date 21/01/2013
Anticipated end date 30/12/2016
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet Cyberonics Europe BVBA Clinical Department +32 2 720 95 93
Target number of participants 150 patients. The enrollment period will end when 150 implanted patients have a least one follow-up assessment post-baseline
Interventions Data from all investigative sites will be combined in the computation of summary statistics. Data will be summarized with respect to each of the parameters that include enrollment and disposition summaries, demographics and baseline disease characteristics. VNS Therapy effectiveness measures and safety measures.
Primary outcome measure(s) Primary objective is to evaluate effectiveness of VNS Therapy in patients with drug resistant epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France.

Primary endpoint: response rate using a summary of participant seizure diary.
Secondary outcome measure(s) The secondary objectives are to assess effectiveness endpoints, safety and tolerability of VNS Therapy in patients with epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France.
Secondary endpoints:
1. Visit-wise Response Rate
2. Seizure frequency
3. Seizure severity
4. Health Status
5. Quality of Life
Sources of funding Cyberonics Inc. (Belgium)
Trial website
Publications
Contact name Dr  Elizabeth  Landre
  Address CH Sainte-Anne
rue Cabanis 1
  City/town Paris
  Zip/Postcode 75014
  Country France
Sponsor Cyberonics Europe BVBA (Belgium)
  Address Belgicastraat 9
  City/town Zaventem
  Zip/Postcode 1930
  Country Belgium
Date applied 04/03/2013
Last edited 26/04/2013
Date ISRCTN assigned 26/04/2013
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