intractable epilepsy
Conditions
Interventions
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged 8 to 60 years; 2. Those with good compliance who can cooperate with the whole clinical trial; 3. Those who did not participate in other clinical trials within three months; 4. Those with epilepsy at least once a month; 5. Those who received regular antiepileptic drugs under the guidance of neurologists, failed to effectively control the seizure, and were diagnosed as drug refractory epilepsy; or those who needed surgery; 6. Those who can understand the purpose of the test, voluntarily participate in and sign the informed consent; 7. Those who are willing to follow up and evaluate according to the requirements of the validation scheme.
Exclusion criteria
Exclusion criteria: 1. Those with infection at the operation site; 2. Those with hemorrhagic constitution or coagulation dysfunction (prothrombin time Pt = 18S); 3. Those with allergy to implanted electrode; 4. Those are in critical condition and are difficult to make accurate evaluation on the effectiveness and safety of the device; 5. Those with mental illness, peptic ulcer or poor general condition; 6. Those with arrhythmia, asthma or active lung disease; 7. Those with insulin dependent diabetes; 8. Those with poor compliance judged by researchers and unable to complete the study as required;; 9. Women who are pregnant or have intention of pregnancy in the past half year, and lactating women; 10. Other subjects not suitable for the clinical trial judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of EEG signal recording;Success rate of SEEG implantation;Success rate of Radiofrequency thermocoagulation;Product clinical evaluation;Device related AE;Laboratory examination;Occurrence rate of AE or SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of EEG signal change before and after Radiofrequency thermocoagulation;Evaluation of therapeutic effect of epilepsy; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital Capital Medical University
Outcome results
None listed