Epilepsy
Conditions
Interventions
Treatment group:Turn on the switch of the implant
Control group:faked turn on the switch of the implant
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for drug-resistant epilepsy published by the International League Against Epilepsy in 2010: Based on the type of epileptic seizures, at least two well tolerated antiepileptic drugs selected and used correctly, either alone or in combination, and the duration of no seizures in patients should not reach three times the longest interval between seizures before treatment or one year; 2. Age = 6 years old and = 70 years old, gender not limited; 3. No treatable causes of epilepsy have been found, or treatment for the causes has failed, or the patient is unwilling to choose surgical treatment, the treatable causes of epilepsy include: 1) Structural causes suitable for surgical treatment after reasonable preoperative evaluation; 2) Medication or special dietary treatments can control the metabolic causes of epileptic seizures, such as vitamin B6 for pyridoxine dependent epilepsy and ketogenic diet for epilepsy caused by type I glucose transporter deficiency; 3) Immunotherapy can control the immunological causes of epileptic seizures; 4. At least 4 seizures occurred 4 weeks before surgery, with a maximum interval of no more than 10 days between seizures; 5. The subjects and their families are able to fully understand the therapy, voluntarily participate in this trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of bilateral or unilateral vagus nerve injury or disconnection; 2. Subjects whose physical condition is deemed unsuitable for instrument implantation surgery by clinical physicians (such as those with a history of allergies to anesthetics, local infections or foreign bodies at the planned implantation site, etc.); 3. Complicated with malignant tumor, serious cardiopulmonary abnormality, progressive nervous system disease, asthma, peptic ulcer, insulin dependent diabetes or poor general condition and other surgical contraindications; 4. Subjects with severe mental illness, cognitive impairment, and inability to cooperate with surgery, program control, and follow-up; 5. Subjects who are breastfeeding, pregnant, or planning to become pregnant during the trial period; 6. Subjects with age dependent epilepsy syndrome that may self limit in the short term; 7. There are implants in the body such as pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc; 8. Subjects with a known history of allergies to implanted vagus nerve stimulation systems and materials in contact with the human body (such as titanium, epoxy resin, liquid silicone rubber, etc.); 9. Subjects undergoing ultrasound therapy and diathermy therapy; 10. Participants who have participated in clinical trials of other drugs or medical devices within the past 3 months; 11. Any other subjects deemed unsuitable by the researcher to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of seizures 16 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improve efficiency;Proportion of subjects with modified Engel grading I or II after surgery;Proportion of postoperative McHugh grade I or II subjects;Improvement rate of seizures 30 weeks after surgery;Changes in Quality of Life Scores (QOLIE-31, QOLIE-16) of Epilepsy Patients Compared to Baseline;Equipment operation performance evaluation; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed