Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Beijing Pins Medical

Status: Unknown

Conditions: Refractory Epilepsy

Treatments: Device: PINS Vagus Nerve Stimualtor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03062514

PINS-026

Details and patient eligibility

About

Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Enrollment: 84 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Experimental

Experimental group

Description:

Subjects'Vagus Nerve stimulator is on always

Treatment:

Device: PINS Vagus Nerve Stimualtor

Control

Sham Comparator group

Description:

Subjects'Vagus Nerve stimulator is off from enrollment to 3 month

Treatment:

Device: PINS Vagus Nerve Stimualtor