French vagus nerve stimulation (VNS) epilepsy registry

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN72921325

Enrollment

150

Registered

2013-04-26

Start date

2013-01-21

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-resistant epilepsy Nervous System Diseases Epilepsy

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 summ

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria The investigator should refer to the instructions for VNS Therapy use

Design outcomes

Primary

Measure	Time frame
Response rate, measured using a summary of participant seizure diary at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026