French vagus nerve stimulation (VNS) epilepsy registry
| ISRCTN | ISRCTN72921325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72921325 |
| Secondary identifying numbers | E-104 |
- Submission date
- 04/03/2013
- Registration date
- 26/04/2013
- Last edited
- 17/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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 followed for about 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?
January 2013 to June 2017
Who is funding the study?
LivaNova Belgium N.V.
Who is the main contact?
Mr Wim Van Grunderbeek
Clinical Department
+32 (0)2 720 95 93
Contact information
Scientific
CH Sainte-Anne
rue Cabanis 1
Paris
75014
France
Study information
| Study design | Post-market long-term prospective observational multi-site study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 vagus nerve stimulation therapy in France |
| Study acronym | E-104 |
| Study objectives | 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. The primary objective is to evaluate the effectiveness of VNS Therapy in patients with drug resistant epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France. The secondary objectives are to assess the 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. |
| Ethics approval(s) | Ethics Board: CPP île de France 3, 05/12/2012, ref: SC2995 |
| Health condition(s) or problem(s) studied | Drug-resistant epilepsy |
| Intervention | 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. If a patient agree to take part, he/she will be followed for approximately 27 months (2 visits pre-implant & 4 visits post-implantation at 6, 12, 18 and 24 months). |
| Intervention type | Other |
| Primary outcome measure | Response rate, measured using a summary of participant seizure diary at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant |
| Secondary outcome measures | Measured at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant: 1. Visit-wise response rate – percent (proportion) of patients who achieved a reduction of ≥ 50% in seizure frequency of all seizure types combined from baseline at each visit time-point after VNS device implant, measured by seizure frequency data in seizure diary 2. Seizure frequency of all seizures combined, measured using a seizure diary 3. Seizure severity, measured using the NHS3 scale 4. Health status, measured using EQ-5D and EQ-5D-Y 5. Quality of life, measured using Qolie-31-P and Qolie-AD-48 |
| Overall study start date | 21/01/2013 |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 150 patients. The enrollment period will end when 150 implanted patients have a least one follow-up assessment post-baseline |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria The investigator should refer to the instructions for VNS Therapy use |
| Date of first enrolment | 21/01/2013 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- France
Study participating centres
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
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France
Sponsor information
Industry
Program Manager Neuromodulation
Ikaroslaan 83
Zaventem
1930
Belgium
"ROR" |
https://ror.org/053mjnp36 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Results will be available as of October 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The data will be stored on a secured server at the sponsor’s site and won’t be accessible via a weblink. |
Editorial Notes
17/01/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/12/2016 to 30/06/2017.
2. The sponsor/funder was changed from Cyberonics Europe BVBA (Belgium)/Cyberonics Inc. (USA) to LivaNova Belgium N.V. (Cyberonics merged with Sorin and became LivaNova).
