NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs012210049

Registered date:15/11/2021

Epilepsy treatment with percutaneous vagus nerve stimulation

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedStructual focal epilepsy
Date of first enrollment15/11/2021
Target sample size2
Countries of recruitment
Study typeInterventional
Intervention(s)Percutaneous auricular vagus nerve stimulation

Outcome(s)

Primary OutcomeRate 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).
Secondary OutcomeSafety 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
Age maximum< 60age old
GenderBoth
Include criteriaThose 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 criteriaThose 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

Contact

Public contact
Name Hideaki Shiraishi
Address North 15, West 7, Kita-ku, Sapporo, Hokkaido Hokkaido Japan 060-8638
Telephone +81-11-706-5954
E-mail 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
E-mail siraisi@med.hokudai.ac.jp
Affiliation Hokkaido University Hospital