Drug-resistant epilepsy Drug-resistant epilepsy
Conditions
Interventions
For patients with drug-resistant epilepsy scheduled for implanted vagus nerve stimulation (iVNS) therapy, seizure frequency will be measured for 1 month using transcutaneous auricular vagus nerve stim
taVNS
Sponsors
Shimada Seijiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with drug-resistant epilepsy who meet all of the following criteria: 1. Administered a cumulative total of 2 or more types of anti-seizure medications. 2. Administered anti-seizure medications for 1 year or longer. 3. Occurrence of seizures at least once a month. (2) Patients scheduled for VNS implantation surgery. (3) Patients aged 18 years or older at the time of consent. (4) Gender is not specified. (5) Patients (or their legally acceptable representatives) who have provided voluntary written consent after receiving a full explanation regarding participation in this study and fully understanding the contents. (6) Patients capable of outpatient visits according to the study schedule.
Exclusion criteria
Exclusion criteria: (1) Patients for whom auricular stimulation is difficult due to severe heart disease (e.g., bradycardia, pacemaker implantation) or skin disease. (2) Patients with metal implants located above the neck level. (3) Patients with facial or ear pain, or trauma to the ear. (4) Patients for whom study compliance is difficult due to severe cognitive impairment, psychiatric disorders, or time constraints of guardians. (5) Patients scheduled to undergo open cranial epilepsy surgery between the time of obtaining consent and the end of the study period. (6) Patients who are pregnant or possibly pregnant. (7) Other patients deemed inappropriate for participation in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pearson's product-moment correlation coefficient between the rate of change in seizure frequency during the 1-month taVNS implementation period (relative to the 1-month baseline prior to taVNS) and the rate of change in seizure frequency during the most recent 1 month at 1 year post-iVNS implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Spearman's rank correlation coefficient between the rate of change in seizure frequency during the 1-month taVNS implementation period (relative to the 1-month baseline prior to taVNS) and the rate of change in seizure frequency during the most recent 1 month at 1 year post-iVNS implantation. (2) ROC-AUC of the rate of change in seizure frequency before and after taVNS, with the presence or absence of change in seizure frequency after iVNS implantation (responder/non-responder) as the outcome. (3) Correlation between the rate of change in seizure frequency during the 1-month taVNS implementation period (relative to the 1-month baseline prior to taVNS) and the rate of change in seizure frequency during the most recent 1 month at 6 months and 2 years post-iVNS implantation. (4) Association analysis between the amount of change in HRV indices (SDNN, RMSSD, LF, HF, LF/HF ratio) calculated from ECG data acquired during rest before taVNS and during taVNS stimulation, and the rate of change in seizure frequency before and after taVNS as well as the rate of change in seizure frequency after iVNS implantation. (5) Stimulation compliance rate during the 1-month taVNS implementation. (6) Sensitivity analysis based on the presence or absence of anti-epileptic drug adjustments from the start date of taVNS to 1 month after the start of taVNS. | — |
Contacts
Public ContactSeijiro Shimada
The University of Tokyo Hospital
Outcome results
None listed