Structural focal epilepsy
Conditions
Interventions
The stimulating electrode will be attached to the left ear lobe and the investigational treatment will
be administered for 4 hours per day
Sponsors
Ueda Yuki
Shiraishi Hideaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (Primary registration) 1.Patients with a diagnosis of epilepsy attributable to structural/metabolic causes or classified into distinct specific symptom groups according to international league against epilepsy classification of the epilepsies(2017) 2.Patients ages over 12 years old and under 60 years old at the time of informed consent 3.Patients who have been taking two or more anti-seizure medications for at least 12 weeks before primary registration and whose dosage and administration are constant 4.Patients with at least 18 focal seizures (focal impaired awareness seizures, focal aware seizures, and focal to bilateral tonic-clonic seizures) during the 12 weeks before primary registration 5.Patients without cognitive abnormalities Criteria: Patients who graduated from a regular class or attended a regular class at the end of their education, and who were judged by the principal investigator or the subinvestigator to have no cognitive problems for participation in the study 6.Patients not on ketogenic diet. Alternatively, patients who have not changed their diet for at least 16 weeks prior to primary enrollment if they are on a ketogenic diet 7.Patients who, at the discretion of the principal investigator or the subinvestigator, are considered to be capable of adhering to the protocol and to the visit schedule and use of the investigational device 8.Patients who receive sufficient information to participate in the clinical trial and for whom written informed consent can be obtained on their own free will. For minors, patients for whom consent from the legally acceptable representative can also be obtained (Secondary registration) 1.Patients whose dose and administration of anti-seizure medications have remained constant since the primary registration in the pre-observation period 2.Patients with 12 or more focal seizures (focal impaired awareness seizures, focal aware seizures, and focal to bilateral tonic-clonic seizures)in the 56 days before secondary enrollement during the pre-observation period. 3.Patients not on ketogenic diet. Alternatively, if the patient is on a ketogenic diet, there is no change in the content of the diet since the first registration, and the patient is unlikely to require a change during the clinical trial
Exclusion criteria
Exclusion criteria: (Primary registration) 1.Patients with a history of progressive brain lesions 2.Patients receiving concomitant VNS therapy or patients with a history of VNS therapy. 3.Patients scheduled to undergo surgical treatments for epilepsy during the clinical trial 4.Patient in pregnancy. Female patients who wish to become pregnant during the clinical trial 5.Female patients unable to perform effective contraception* during the clinical trial *Examples of contraceptive methods: condoms, pessaries, oral contraceptives, use of intrauterine devices, etc 6.Patients with cutaneous hypersensitivity and a history of cutaneous symptoms due to metals, etc. 7.Patients with severe renal impairment (Creatinine clearance according to Cockcroft-Gault equation is below 60 mL/min) 8.Patients using pacemakers 9.Patients who underwent left or bilateral cervical vagotomy 10.Patients with burns, injuries, etc. in the left ear 11.Patients at risk or with a history of vagal nerve stimulation induced symptoms (bradycardia, cough, vomiting, etc.), which are considered unacceptable by the principal investigator or subinvestigator 12.Patients with a history of psychogenic non-epileptic seizures 13.Patients with active central nervous system infection, demyelinating disease, neurodegenerative disease, or central nervous system disease that progresses during the study period and may affect the evaluation of the results of the study 14.Patients who were hospitalized due to status epilepticus within 1 year before primary registration 15.Patients with psychiatric disorders 16.Patients scheduled to receive additional anti-seizure medications during the clinical trial 17.Patients whom the principal investigator or the subinvestigator considered to be inappropriate as subjects (Secondary registration) 1.Patients who were hospitalized due to status epilepticus in the pre-observation period 2.Patients whom the principal investigator or the subinvestigator considered to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of the rate of decrease in the incidence of epileptic seizures per 28 days in each period of the treatment period (double-blind period) compared with the pre-observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Responder rate 2. Safety of MY-taVNS treatment 3. Change in QOL before and after MY-taVNS treatment (using the SF-36) 4. Changes in the rate of decrease in the incidence of epileptic seizures during the open-label extension period 5. Evolution of the decreasing rate of epileptic seizure frequency at 4 weeks after discontinuation and completion of investigational treatment | — |
Contacts
Public ContactChika Holloway
Hokkaido University Hospital
Outcome results
None listed