epilepsy
Conditions
Interventions
Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period
Sponsors
Hokkaido Univesity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: atients who meet all of the following criteria are eligible (i) Male and female patients who are at least 6 years old and less than 60 years old at the time of obtaining consent. (ii) Patients who have been diagnosed with refractory epilepsy based on clinical seizure symptoms, electrophysiological tests, and course of treatment. (iii) Patients who have received sufficient explanation for participation in this study, and who have given their or their surrogate's free and voluntary written consent after fully understanding the consent explanation document and assent document. (iv) Persons who have at least one focal seizure (focal seizure with impairment of consciousness, focal seizure without impairment of consciousness, or focal onset bilateral tonic-clonic seizure) each week despite treatment with two or more antiepileptic drugs.
Exclusion criteria
Exclusion criteria: Patients with any one of the following conditions shall be excluded (i) Patients with a history of progressive brain lesions (2) Patients receiving concomitant vagus nerve stimulation therapy (iii) Pregnant or lactating mothers (iv) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances (5) Patients who are abstinent or unable to use effective contraceptive methods during the period of participation in the study (vi) Patients who have difficulty in oral intake (vii) Patients with severe renal dysfunction (creatinine clearance less than 30 ml/min) (viii) Other subjects deemed inappropriate as research subjects by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period | — |
Countries
Japan
Contacts
Public ContactYuichi Kojima
Hokkaido Univesity Hospital Respiratory
Outcome results
None listed