VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home

Launched by MICROTRANSPONDER INC. · Jan 10, 2023

Keywords

ClinConnect Summary

The VNS-REHAB At-Home study is looking at a new way to help people who have had an ischemic stroke and are having trouble using their arms. This trial will involve up to 150 participants who have the Vivistim System implanted, which is a device that helps improve arm movement through a special type of therapy at home. Instead of going to a clinic for treatment, participants will receive therapy at home from trained therapists, along with a device they can use themselves to help stimulate their nerves during rehabilitation.

To be eligible for this study, participants need to be adults who have either already had the Vivistim System implanted or are scheduled to have it done. Unfortunately, younger patients (under 18) and pregnant women cannot participate. Those who join the study can expect to receive personalized therapy sessions at home over the course of several weeks, focusing on improving their arm movement and overall function. It’s important to note that the surgery to implant the Vivistim System is not part of this study but must be done beforehand.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient implanted or scheduled to be implanted commercially with the Vivistim System.
• • Patient assessed as able to receive therapy in their home.
• Exclusion Criteria:
• • Patient aged 18 or younger.
• • Pregnant women