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

Refractory Epilepsy Clinical Trial

Official title:

Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062514
• Other study ID #: PINS-026
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: December 29, 2017
• Start date: October 9, 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2017
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia, PhD
• Phone: 010-60736388
• Email: pins_medical[@]163.con
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Device:
• PINS Vagus Nerve Stimualtor
PINS Vagus Nerve Stimualtor

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in seizure frequency		12 weeks of stimulation
Secondary	Changes in seizure frequency		6?12?24 weeks of stimulation
Secondary	Engel scale description		6?12?24 weeks of stimulation
Secondary	Changes in the Number of Anti-epileptic Drugs		6?12?24 weeks of stimulation
Secondary	GESELL mental development scales		12?24 weeks of stimulation