None listed
Conditions
Interventions
Medical Device : The subjects wore either the test device (Active stimulation) or the control device (Sham stimulation) through random assignment, and after 8 weeks of stimulation, a 4-week latent per
Sponsors
TODOC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with focal epilepsy according to the International League Against Epilepsy(ILAE) classification system for epilepsy 2. Men and women aged 19 to 65 years at the time of screening 3. Patients who have used two or more antiepileptic drugs but have experienced four or more complex partial or grand mal seizures within 8 weeks from the time of screening 4. Those who weigh 35 kg or more 5. Those who do not plan to become pregnant during the clinical trial period and, in the case of women of childbearing potential, those who have agreed to an effective contraceptive plan 6. Those who voluntarily agreed to the informed consent form after hearing an explanation of the clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients currently receiving treatment for severe cardiovascular, neurological, psychiatric, infectious diseases, and malignant tumors, excluding epilepsy 2. Patients taking antiepileptic drugs, antidepressants, or other neuroactive drugs that affect dopamine and norepinephrine (e.g., methylphenidate, atomoxetine, etc.) 3. Patients who developed status epilepticus within 4 weeks of the screening time 4. Patients who have received or are receiving other stimulation procedures, such as vagus nerve or deep brain stimulation, in the past 5. Patients with newly developed epilepsy due to stroke, etc. 6. Patients with a history of brain surgery due to cerebral hemorrhage, etc. 7. Patients with psychogenic non-epileptic seizures 8. Patients with seizure clusters or other reasons that make the counting of the number of seizures inaccurate 9. Patients with confirmed pregnancy or breastfeeding 10. Other individuals judged by the investigator to be unsuitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of seizure frequency compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in seizure frequency compared to baseline;Response scale of the rate of decrease in seizure frequency compared to baseline;Liverpool Seizure Severity Scale;Reduction rate of seizure frequency compared to baseline between the test group and the control group within the two groups;Quality of Life in Epilepsy-31(QOLIE-31) Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Min Shon
Samsung Medical Center
Outcome results
None listed