20
Participants
Start Date
February 15, 2021
Primary Completion Date
November 30, 2023
Study Completion Date
April 30, 2025
Active Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with upper extremity rehabilitation. VNS stimulation as described in the current study consists of 0.5 s trains of 0.8 mA 100 µs biphasic pulses delivered at 30 Hz. Stimulation trains are delivered only during rehabilitation.
Placebo Vagus Nerve Stimulation
During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.
RECRUITING
Baylor University Medical Center, Dallas
Lead Sponsor
Wings for Life
OTHER
Defense Advanced Research Projects Agency
FED
The University of Texas at Dallas
OTHER
University of Texas Southwestern Medical Center
OTHER
Baylor Research Institute
OTHER