This is an informational page for a U.S. clinical trial for the treatment of stroke. The trial is using a new therapy developed by MicroTransponder. Enrollment is now open.
The Vivistim™ System clinical trial for the treatment of stroke is open to all U.S. residents who have had a stroke at least 4 months ago but not more than five years ago. There are 3 sites and a total of 20 patients will be enrolled. Applicants must be between the ages of 30 and 80. 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 20 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 have been used before, while the other group will use VNS settings that have not been used before. 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 new settings initially can come back and try the other settings. All patients can then return for yearly rehabilitation and VNS sessions (up to 6-weeks of 3 times a week sessions).
If you are selected by the site for further evaluation, you will undergo additional assessments. Additional requirements include being in generally good health, being an appropriate candidate for surgery (the surgeon will check you to make sure), not be taking medications thought to interfere with brain chemicals called neuromodulators, and not having any significant cardiac (heart) history.
For more information on the therapy, click on button below.
This is only a brief description of the basic eligibility criteria. The study investigator will assess whether or not you meet all study entry criteria. Because the study has a number of visits over the course of a year, you must live close to one of the two study centers or be willing to pay for your own travel to the center.
If you believe you might meet the entry criteria and are still interested in learning more about the device and this research study, please click the button of the appropriate site and you will be contacted shortly.
Below you will find links to further information on the trial at the 3 sites involved in the clinical trial. The cities are:
- Dallas, Texas (University of Texas Southwestern)
- Houston, Texas
- Minneapolis, Minnesota
IF YOU LIVE OUTSIDE THE U.S. OR NOT NEAR THE 3 TRIAL SITES, AND WOULD LIKE TO BE PLACED ON OUR STROKE UPDATE LIST – PLEASE CLICK THE BUTTON BELOW.