Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB) "VNS-REHAB"

Recruiting

Phase N/A Results N/A

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...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 19 July 2017.

1 Jul 2017 24 Apr 2017 30 Jun 2019 30 Jun 2021 1 Jul 2017 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

Not available

Contacts