JRCT ID: jRCTs012210049
Registered date:15/11/2021
Epilepsy treatment with percutaneous vagus nerve stimulation
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Structual focal epilepsy |
Date of first enrollment | 15/11/2021 |
Target sample size | 2 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Percutaneous auricular vagus nerve stimulation |
Outcome(s)
Primary Outcome | 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. Response rate (percentage of patients with a 50% or greater reduction in the incidence of epileptic seizures). |
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Secondary Outcome | Safety in the administration of taVNS therapy, and the presence or absence of diseases, etc. QOL changes before and after taVNS therapy (according to SF-36). |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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Age maximum | < 60age old |
Gender | Both |
Include 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 |
Exclude 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) |
Related Information
Primary Sponsor | Shiraishi Hideaki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Hideaki Shiraishi |
Address | North 15, West 7, Kita-ku, Sapporo, Hokkaido Hokkaido Japan 060-8638 |
Telephone | +81-11-706-5954 |
siraisi@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Hospital |
Scientific contact | |
Name | Hideaki Shiraishi |
Address | North 14, West 5, Kita-ku, Sapporo, Hokkaido Hokkaido Japan 060-8648 |
Telephone | +81-11-716-1161 |
siraisi@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Hospital |