Epilepsy
Conditions
Interventions
Closed-loop TIS stimulation group:The closed-loop electrical stimulation was regulated according to real-time EEG recording, and the regulation duration of closed-loop electrical stimulation was 2-6 h
Closed-loop TIS sham stimulation group:Closed-loop electrical stimulation was regulated according to real-time EEG recording, and the duration of closed-loop sham stimulation regulation was 2-6h
Sponsors
Children's Hospital Affiliated to Nanjing Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. According to the latest epilepsy diagnostic criteria issued by the International League Against Epilepsy (ILAE), the patient has been professionally diagnosed with epilepsy; 2. Secondly, the patient falls under the category of drug-resistant epilepsy, meaning that after treatment with at least two first-line anti-epileptic drugs at adequate doses and durations, seizures cannot be effectively controlled; 3. Furthermore, the patient is between 2 and 18 years old, with no restriction on gender; 4. Finally, the patient must voluntarily participate in this study, sign an informed consent form, and have the ability to cooperate with all examinations and follow-ups.
Exclusion criteria
Exclusion criteria: 1. Suffering from brain tumors or other central nervous system degenerative diseases; 2. There are obvious organic changes in the brain; 3. Severe cognitive dysfunction; 4. Pseudo-epileptic seizures; 5. Generalized or special types of hereditary epilepsy; 6. Had undergone surgical treatment for epilepsy within 6 months before implantation; 7. Participated in other clinical trials within 3 months before the operation; 8. Those who already have mental disorders and are unable to undergo relevant examinations as required; 9. Other serious physical disorders or severe abnormalities in liver and kidney functions as shown in laboratory tests, which affect the follow-up. 10. There are objective factors that prevent the completion of follow-up visits (such as economic factors, transportation factors, etc.); 11. Abnormal laboratory tests during the screening period, or other abnormal laboratory tests considered to be of clinical significance; 12. Those who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discharge characteristics of Pre-ictal EEG recordings before and after stimulation for each patient;The number of seizures before and after stimulation for each patient;The number of seizures before and after stimulation for each patient;Functional magnetic resonance imaging, fMRI; | — |
Countries
China
Contacts
Public ContactZhang Gang
Children's Hospital Affiliated to Nanjing Medical University
Outcome results
None listed