Summary of Purpose
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (<30, >30) and baseline FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is...Read More →
The following dates are available for this trial. Trial information last updated on 24 April 2018.
|1 Jul 2017||24 Apr 2017||30 Jun 2019||30 Jun 2021||1 Apr 2018||Unavailable|
|Start Date||First Received||1st Completion||Completion||Verification||Results|