Structual focal epilepsy epilepsy structual focal
Conditions
Interventions
Percutaneous auricular vagus nerve stimulation
Therapy
Sponsors
Shiraishi Hideaki
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactHideaki Shiraishi
Hokkaido University Hospital
Outcome results
None listed