Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      By doing this study, the investigators hope to learn provide safety data that can be used to
      generate a larger phase III clinical trial. If successful, it would promote the development
      of a new treatment for PD in which patients are able to provide their own tissue as a source
      of a supportive environment for the injured and dying cells and thereby possibly stopping the
      progression of the illness or even improve the symptoms of PD.

      The purpose of this research is to gather information on the safety and feasibility of nerve
      graft implantation is. The results of this study will be shared with the University of
      Kentucky, Center for Clinical and Translational Science (group providing financial support
      for the study) and other federal agencies, if required.

      The overall goal of this research is to develop a novel, regenerative treatment strategy for
      idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to
      patients.
    

Detailed description: 
      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.
    

Intervention name(s): Implantation of the Peripheral Nerve Graft
Intervention type(s): Procedure
Intervention description(s): The preparatory surgery for harvesting the peripheral nerve graft will take place in the operating room at the time of the Stage I surgery for the DBS procedure. The nerve exposure and preparation will take approximately 15 minutes of operating time in addition to the DBS procedure which typically takes 75-90 minutes.
The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. The graft harvesting and implantation will take approximately 15 minutes in addition to the 4 hours that is needed for the DBS surgery. The subject's peripheral nerve graft will be implanted into the substantia nigra unilaterally. This is a single arm trial to assess safety and feasibility.
Other intervention name(s): Peripheral Nerve Graft
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Deep Brain Stimulation; Peripheral Nerve Graft