Clinical Trial: Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
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 Summary:
Sponsor: Beijing Pins Medical Co., Ltd
Current Primary Outcome: Changes in seizure frequency [ Time Frame: 14 weeks of stimulation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes in seizure frequency [ Time Frame: 8、14、26 weeks of stimulation ]
- Engel scale description [ Time Frame: 8、14、26 weeks of stimulation ]
- Changes in the Number of Anti-epileptic Drugs [ Time Frame: 8、14、26 weeks of stimulation ]
- GMDS（Griffiths mental development scales）-ER [ Time Frame: 14、26 weeks of stimulation ]
Original Secondary Outcome: Same as current
Information By: Beijing Pins Medical Co., Ltd
Dates:
Date Received: February 15, 2017
Date Started: April 2017
Date Completion: March 2018
Last Updated: February 20, 2017
Last Verified: February 2017
