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

Not Applicable

• Conditions: Refractory Epilepsy
• Interventions: Device: PINS Vagus Nerve Stimualtor

• Registration Number: NCT03062514
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-10-09
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-02
• Primary Completion: 2018-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	PINS Vagus Nerve Stimualtor	Subjects'Vagus Nerve stimulator is on always
Control	PINS Vagus Nerve Stimualtor	Subjects'Vagus Nerve stimulator is off from enrollment to 3 month

Primary Outcome Measures

Name	Time	Method
Changes in seizure frequency	12 weeks of stimulation

Secondary Outcome Measures

Name	Time	Method
GESELL mental development scales	12、24 weeks of stimulation
Changes in seizure frequency	6、12、24 weeks of stimulation
Engel scale description	6、12、24 weeks of stimulation
Changes in the Number of Anti-epileptic Drugs	6、12、24 weeks of stimulation

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China