During the study your clinician will first test the device and settings in the office. They will do this at each rehabilitation session. They will also discuss any at-home exercises you should perform.
Your schedule will be:
- Return 3 times a week for 6-weeks and have 2-hour rehabilitation plus VNS sessions.
- Return 1, 30, and 90-days after the last rehabilitation + VNS session for assessments. These assessments will check how your arm and hands are functioning after receiving rehabilitation and VNS.
- If you are in the group testing settings lower than the previous settings, you will return again after the 90th day and have another 6-weeks of 3 times a week rehabilitation plus regular VNS.
- Both groups will then return quarterly for the first year and then yearly for the next 3-years for assessments of arm and hand function. Both groups can also have yearly sessions of up to 6-weeks of rehabilitation and VNS therapy.
You will also be given a calendar diary to record any at-home rehabilitation exercises and document any other comments.
You will have repeat physical and neurological examinations after 6 weeks and 12 months of treatment. Your medications and any experiences of discomfort (adverse events) or difficulties will be recorded by the study personnel. You will also be asked about your mood at the start and end of the study.
Throughout the study, you should return promptly for all study visits, report any changes in your medications (over-the-counter and prescription), report any missed doses of your medication, and report any changes in how you feel to the investigator. Missed visits may cause missing data, which may cause your data to be unusable.
If you are still interested in being involved in this study, press “continue”