Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

July 31, 2015

Study Completion Date

September 30, 2015

Conditions
Parkinson's Disease
Interventions
PROCEDURE

Implantation of the Peripheral Nerve Graft

"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."

Trial Locations (2)

40475

University of Kentucky Medical Center, Lexington

40536

University of Kentucky Medical Center, Lexington

All Listed Sponsors
collaborator

University of Kentucky

OTHER

lead

Craig van Horne, MD, PhD

OTHER

NCT01833364 - Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation | Biotech Hunter | Biotech Hunter