Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

Inclusion Criteria:

• Age: ≥3 years old; gender is not limited;
• Patients with clinically diagnosed drug-resistant epilepsy, suitable for vagus nervestimulation therapy;
• At least 6 seizures per month;
• Patients with a history of increased heart rate (tachycardia) associated with seizureonset based on clinical data obtained from medical history, admission/hospital charts,or prior neurophysiologic evaluations;
• When the patient is lying on the left side and in an upright position, from theproposed electrode position on the neck to the proposed pulse generator on the chest,the peak-peak R-wave of the ECG should be higher than 0.40mV;
• Patients who are willing to undergo EMU phase assessment and activate the automaticmode function during this period;
• Patients must be in good general health and ambulatory;
• Children and guardians must be willing and able to give informed consent;
• Patients and their families have good compliance and can cooperate with the completionof postoperative follow-up requirements.

Exclusion Criteria:

• Patients have had a bilateral or left cervical vagotomy;
• One or both sides of the vagus nerve have lesions or damage;
• Patients have a history of VNS Therapy;
• Patients with a history of status epilepticus within 1 year prior to enrollment;
• Patients with a history of mental illness or pseudoepileptic seizures or epilepsycaused by intracranial space-occupying lesions;
• Patients currently use, or are expected to use, short-wave diathermy, microwavediathermy, or therapeutic ultrasound diathermy;
• Patients expected to require full body magnetic resonance imaging;
• VNS therapeutic system implants will bring unacceptable surgical or medical risks topatients (according to the judgment of the investigator);
• Patients with surgical contraindications identified by surgeons and anesthesiologistssuch as tumors, insulin-dependent diabetes mellitus or poor general condition;
• A record of clinically significant seizure-related bradycardia (heart rate below 50bpm);
• Patients prescribed drugs specifically for a cardiac or autonomic disorder that in theinvestigator's opinion would affect heart rate response unless the patient has ictaltachycardia while taking said drugs. These include, but are not limited to, betaadrenergic antagonists ("beta blockers");
• Patients with known clinically significant arrhythmias, and patients with clinicallysignificant arrhythmias identified by 24-hour ambulatory ECG recordings obtained atthe screening visit;
• Adult patients with severe mental illness, severe cognitive impairment, history ofsevere depression, or suicidal tendencies, which, in the judgment of the investigator,would pose an unacceptable risk to the patient or prevent the patient fromsuccessfully completing the study;
• Abusing alcohol or use narcotic drugs;
• Women who are pregnant. Women of childbearing age must take a pregnancy test;
• Patients currently enrolled in another investigational study;
• Those deemed unsuitable by the researcher.