Clinical Trial: Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
Brief Summary: The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
Detailed Summary:
Sponsor: Beijing Pins Medical Co., Ltd
Current Primary Outcome: Changes in seizure frequency from baseline to the seizure count evaluation period 6 month [ Time Frame: 6 month of stimulation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 1,3,6,months of stimulation ]
- Change from Baseline in the Engel and McHugh description [ Time Frame: At 1,3,6 months ]
- Overall WISC Score in Patients from Baseline [ Time Frame: Mean change from baseline WISC Overall Score at 1,3,6months ]
Original Secondary Outcome: Same as current
Information By: Beijing Pins Medical Co., Ltd
Dates:
Date Received: December 13, 2015
Date Started: October 2016
Date Completion:
Last Updated: October 7, 2016
Last Verified: October 2016
