Please select the eligibility criteria that correspond to the clinical trial below.
Title: Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
Brief Summary: The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.


Options:
A: Inclusion Criteria:

* Patients with a clinical diagnosis of medically refractory epilepsy with partial onset seizures suitable for implantation with the VNS Therapy System.
* Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
* Patients must be at least 12 years old.
* Patients must be in good general health and ambulatory.
* Patient or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

* Patients have had a bilateral or left cervical vagotomy.
* Patients currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
* Patients expected to require full body magnetic resonance imaging (MRI).
* Patients have a history of implantation of the VNS Therapy.
* Patients with an IQ known or estimated to be \< 70, history of depression requiring hospitalization, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
* Patients with a history of status epilepticus within 1 year of study enrollment.
* Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained during the baseline period.
* Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
* Patients with a history of psychogenic non-epileptic seizures.
* Women who are pregnant. Women of childbearing age must take a pregnancy test and agree to use an approved method of contraception during the study.
* Patients currently enrolled in another investigational study.
B: Inclusion Criteria:

* Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System.
* Patients with a history of increased heart rate (tachycardia) associated with seizure onset based on clinical data obtained from medical history, admission/hospital charts, or prior neurophysiologic evaluations.
* Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
* Patients having an average of ≥ 3 seizures per month based upon diary or patient reporting for the 3 months prior to the screening visit.
* Patients must have peak-peak R-wave amplitude greater than or equal to 0.40 mV on ECG measured from the proposed electrode location in the neck to the proposed generator location in the chest via surface ECG electrodes in 7 different body positions.
* Patients must be at least 18 years old.
* Patients must be in good general health and ambulatory.
* Patient must be willing and able to complete informed consent.

Exclusion Criteria:

* Patients have had a bilateral or left cervical vagotomy.
* Patients currently use, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
* Patients expected to require full body magnetic resonance imaging.
* Patients have a history of VNS Therapy.
* Patients have a documented history of clinically meaningful bradycardia (heart rate less than 50 bpm) associated with seizures.
* Patients with a significant psychiatric disorder, significant cognitive impairment, history of major depression, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
* Patients with a history of status epilepticus within 3 months of study enrollment.
* Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
* Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained at the screening visit.
* Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
* Patients with a history of only psychogenic or pseudo seizures.
* Women who are pregnant. Women of childbearing age must take a pregnancy test.
* Patients currently enrolled in another investigational study.
C: Inclusion Criteria:

1. Age 3-6
2. At least 6 seizure per month
3. Refractory Epilepsy
4. In good health except epilepsy
5. Patients or his(her) familyscould understand this method and sign the informed consent
6. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
4. Cann't write the epilepsy diary
5. Participating other clinical trial
6. Cann't complate the operation
7. Complete the postoperative follow-up
8. Cann't complete the promgramming
D: Inclusion Criteria:

* Diagnosed as epilepsy;
* With age between 2-18 years old;
* The number and dose of the medication was kept constant no less than eight weeks before intervention;
* The patients or their guardians can count the frequency of the seizures and finish the study.

Exclusion Criteria:

* The patient is receiving the VNS therapy;
* Accompanied with progressive central nervous system diseases;
* Have severe heart, liver ,kidney or blood diseases;
* Be pregnant or having the schedule of pregnancy in the study period.

Answer: D