A Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With Parkinson's Disease Undergoing Deep Brain Stimulation Surgery and Treatment

This pilot study is designed to test the safety and feasibility of the implantation of the subject's own peripheral nerve tissue into an area of the brain called the substantia nigra. Only subjects who have elected to undergo DBS surgery will be asked to participate in this research study. The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. Subjects will be asked to donate a piece of their own peripheral nerve tissue that will be used to create the graft for their implantation. The peripheral nerve tissue is obtained from a small incision (approximately 2 inches) above and on the outer-side of one ankle. The initial incision is created during stage I of the DBS procedure and will take place under general anesthesia. The incision will be closed with internal sutures, and a dressing will cover the incision after the procedure. The nerve will be harvested during stage II of the DBS procedure. This involves opening the same incision using local anesthesia injected around the incision site. Once a small piece (about an inch) of the nerve is removed, the incision will be sutured closed with internal stitches. These stitches will dissolve on their own and will not need to be removed in the office. Follow-up. Subjects will be followed in our clinic for for DBS follow-up visits and treatment, none of those visits are part of this study. Prior to coming in for study visits subjects will need to stop taking their PD medications 12 hours before each visit. Subjects will be allowed to restart their normal PD medication during the examination. Subjects will undergo formal Unified Parkinson's Disease Rating Scale (UPDRS) evaluations at screening and months 1, 3, 6, 9 and 12. In order to visually document potential changes in their Parkinson's Disease symptoms following their DBS surgery, we will be videotaping study related neurological testing sessions. Subject will also be videotaped at screening, and visits 1, 3, 6, 9, 12. A neuropsychological exam will be performed at screening and again at month 12.