This study has two distinct stages: Stage I (Acute), a treatment period of up to 18-weeks of Paired VNS™ for upper limb motor deficits - where patients receive VNS Paired with rehabilitation - provided at-home by a therapist along with self-activated VNS home-therapy on remaining days; Stage II (Long-term), a follow-up period of up to two years during which subjects continue self-activated VNS at-home using a magnet during therapist-prescribed functional tasks. The at-home therapy is a convenience for patients without having to drive or find transportation to a rehabilitation center, as well as reduce possible COVID-19 exposure in a setting with many people.
Stage I of the VNS-REHAB At-Home study includes (ACUTE):
* screening and consent
* pre-therapy baseline evaluation (prior to the start of therapy)
* Paired VNS™ for moderate to severe upper limb motor deficits will be provided in the patient's home by a therapist. Therapy length depends on scheduling between the therapist and subject for the subject's convenience. The intent is that 36 hours of in-home time will be provided over the study duration in two (2) or more visits per week. On days without the therapist-led rehabilitation, subjects will do therapist-prescribed functional activities on their own with magnet-activated VNS (self-activated VNS).
* Therapy assessments: performed after 12, 24, and 36 hours of therapist time in the subject's home.
Stage II includes (Long-Term):
* Therapy assessments at 3, 12, and 24 months after completion of 36 hours of therapist visit duration.
* Ongoing self-administration of at-home VNS during therapist-prescribed activities and rehabilitation outside of therapy visit duration.
* subjects will exit the study after their two-year visit.
