Epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with drug-resistant epilepsy, with a disease duration >=2 years, having tried at least two antiepileptic drugs with poor seizure control, and experiencing a seizure frequency >=4 times per month in the past year; 2. No adjustment of antiepileptic medications within 1 month prior to VNS implantation; 3. Normal swallowing function and maintaining a regular diet; 4. Undergoing VNS treatment for the first time; 5. Both patients and their legal guardians fully understand the treatment protocol and voluntarily agree to participate in this study; 6. Patients who have provided informed consent after comprehensive preoperative counseling, voluntarily signed the informed consent form, and have no contraindications for the surgical procedure;
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone previous surgical interventions such as lobectomy, lesionectomy, or deep brain stimulation (DBS) prior to this procedure; 2. Patients with concurrent peptic ulcer disease, diarrhea, or other gastrointestinal disorders (e.g., colitis, Crohn's disease); 3. Patients who have undergone colorectal surgery or received radiotherapy/chemotherapy within the past 3 years; 4. Patients who have received neuromodulation therapies (e.g., transcranial ultrasound) within 3 months prior to enrollment; 5. Use of antibiotics, corticosteroids, or other medications significantly affecting gut microbiota within 4 weeks before sampling; 6. Patients with progressive neurological disorders or other severe systemic diseases; 7. History of substance/alcohol abuse, psychiatric disorders, or current severe depression/anxiety; 8. Female patients during menstrual period (sampling not permitted); 9. Currently participating in other clinical trials; 10. Pregnant, planning pregnancy, or breastfeeding during the study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| McHugh classification; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse effect;epilepsy frequency;Engel's classification of postoperative outcome; | — |
Countries
China
Contacts
Sanbo Brain Hospital Capital Medical University