40
Participants
Start Date
July 15, 2025
Primary Completion Date
May 31, 2029
Study Completion Date
September 30, 2029
Vagus Nerve Stimulation (VNS) Device
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers active VNS stimulation.
Sham VNS Device
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers sham VNS stimulation.
Upper Extremity Rehabilitation
"Rehabilitation training will be functional and activity-based, focusing on six task categories: reaching and grasping objects, gross movements with objects, flipping objects, inserting objects, self-feeding, and opening and closing containers.~Three 90-minute training sessions per week will be administered by a licensed occupational therapist, over two six-week treatment blocks. Sessions will be paired with either active or sham VNS administration."
RECRUITING
NYU Langone Health, New York
RECRUITING
The University of Texas at Dallas, Richardson
National Institutes of Health (NIH)
NIH
University of Texas at Dallas
UNKNOWN
NYU Langone Health
OTHER