Our study has two phases and everyone will have the opportunity for active treatment.
The first visit will determine your eligibility.
If you meet the study criteria and sign the informed consent form, you will be scheduled for surgery to implant the ReStore System nerve stimulator. The ReStore System sits on the vagus nerve in the neck and triggers vagus nerve stimulation. The surgery to implant the device is expected to take about 60 minutes, and recovery time is expected to take about one week.
Once you have recovered from the surgery, you will begin study treatment. The trial occurs over 2 phases that each includes 18 rehabilitation sessions over 6 weeks. The first phase is randomized, the second is open-label and everyone receives active stimulation. This was done to ensure everyone who is implanted has an opportunity to receive active treatment.