Epilepsy treatment with percutaneous vagus nerve stimulatio

Not Applicable

Recruiting

• Conditions: Structual focal epilepsy; epilepsy structual focal

• Registration Number: JPRN-jRCTs012210049
• Lead Sponsor: Shiraishi Hideaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Those with clinical seizure symptoms and electrophysiologically diagnosed structural focal epilepsy
A person who can understand the consent explanation document / ascent document and can show his / her intention to consent.
Have at least one focal epilepsy per week (focal epilepsy with impairment of awareness, focal epilepsy without impairment of awareness, focal to bilateral tonic-clonic seizure) despite two or more antiepileptic treatments thing

Exclusion Criteria

Those with a history of progressive brain lesions
Those who are using vagus nerve stimulation
Pregnant or lactating
Persons with skin hypersensitivity and a history of skin symptoms due to metals, etc.
Patients who are abstinent or unable to use effective contraception during study participation
Those who have difficulty ingesting
Persons with severe renal dysfunction (creatinine clearance less than 60 ml / min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of decrease in the frequency of epileptic seizures per week during the observation period and duration of taVNS therapy compared to the pre-observation period.<br>Response rate (percentage of patients with a 50% or greater reduction in the incidence of epileptic seizures).

Secondary Outcome Measures

Name	Time	Method
Safety in the administration of taVNS therapy, and the presence or absence of diseases, etc.<br>QOL changes before and after taVNS therapy (according to SF-36).