At the initial visit, you will review the consent document for this study. You will be given the opportunity to ask as many questions as you would like. You can take the consent form home to think about the study and return at a later date to enroll if you would like time to consider participating. Once you sign the consent, we will ask you to complete some questionnaires (stroke impact scale, NIH stroke scale) and we will do some assessments of your arm and hand movements (wolf motor function test; upper limb fugl-myer) to see if you can continue in the study. If you are eligible to continue, the following will occur:
We will collect baseline measures on the above items and others at two visits (your initial visit and a 2nd visit) within a four-week period. If you are still eligible and want to continue, you will then have the device implant surgery. After about one week of recovery, you will then come in 3 times a week for six (6) weeks for a rehabilitation visit that will last about two-hours at each visit. You will receive rehabilitation and VNS at each visit. After the full six-weeks of therapy you will return after one, 30, and 90-days for more assessments.
Device implant surgery will occur within about two weeks of the last assessment test. At implant surgery you will be randomized into a study group. You will be randomly placed into one of the setting groups: this means you have an equal chance of being placed in either group, like the chance of heads or tails with a flipped coin. You and the study site personnel will not know which group you are in. After an approximate one-week recovery period from surgery then study treatment will begin. Your stimulation treatment will be different for the 6 weeks but your rehabilitation treatment will be the same no matter into which group you are placed.
You will then enter the long-term follow-up part of the study. If you are in the group that received the same stimulation as the previous study, you will return for assessments every 3 months through the first year, and then yearly thereafter for a total of 3-years. You can also receive a “booster” week session of rehabilitation and VNS after 6- and 12-months. If you are in the group that tries different (lower) settings you will then start another 6-week session of rehabilitation plus standard VNS (3 times a week for 6-weeks). You will then return for quarterly and yearly visits like the other group.
If you are still interested in being involved in this study, press “continue”