This study, called the Vivistim Registry for Paired VNS Therapy (GRASP), is collecting information on people who have arm and hand weakness after a stroke and are considering treatment with the Vivistim System. The Vivistim System is a device that uses Vagus Nerve Stimulation (VNS) paired with rehabilitation exercises to help improve arm movement. Researchers want to see how well the Vivistim System works in real-world settings. You would be eligible if you are 22 years or older, have arm weakness from an ischemic stroke, and are considering the Vivistim System. The study will measure your arm function using tests like the Fugl Meyer Assessment (FM-A) and Wolf Motor Function Test (WMFT) at 6 months to see if your arm movement improves. The current status of this study is unclear.

Study design

This is an observational study, meaning researchers will collect information without assigning specific treatments. It plans to enroll 1000 participants.

What's involved

Data will be collected at the start, then at 3, 6, and 12 months after implantation, and yearly for up to three years. If you don't get the implant, data can still be collected for comparison.

Compensation

Physicians or sites will receive payment for collecting and sending data. It is not stated whether participants are paid or reimbursed.

Follow-up

You will be followed for up to three years after implantation, with primary outcomes measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.