This is an informational page for a U.S. pivotal clinical trial for the treatment of stroke. The trial is using a new therapy developed by MicroTransponder. Enrollment was completed in 2019 and results will be announced in 2020.
For reference, our NIH Clinical Trial Info can be found at this link: https://clinicaltrials.gov/ct2/show/NCT03131960
The Vivistim™ System clinical trial for the treatment of stroke is open to all U.S. residents who have had a stroke at least 9 months ago but not more than ten years ago. This clinical trial utilizes an implantable device (called the Vivistim™ System), which will require an outpatient surgical procedure to place the device inside your body. All 108 patients in the study will be implanted with the Vivistim™ System. After the surgery and recovery, study subjects will be divided in two groups; one group will use VNS therapy settings that we believe are more optimal, while the other group will use VNS settings that are minimal and less optimal, both settings were used in our previous 17-patient study. Based on our smaller study, we believe one setting may be more effective than the other setting, however both groups will receive the same rehabilitation and physical therapy. The study is “double blinded” – so neither the assessor nor the patient will know which group they are in (only the person setting the device will definitely know); this will help the study to be as accurate as possible. After the initial 6-week therapy period and follow-up assessments, the patients who tried the less optimal settings initially can come back and try the other settings. All patients will return for yearly assessments to monitor the longevity and changes, if any, of upper limb symptom improvements.
If you would like to receive additional information about our therapy, including additional clinical trials or information on future commercial availability, please click on the link below. Note that you will not receive an immediate response, but will be contacted at some point in the future.