Feasibility and Safety of AutoloGous UncondItioneD PEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 7, 2022

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Parkinson's Disease
Interventions
PROCEDURE

Peripheral Nerve Tissue Implantation

At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed. From the biopsied section, the epineurium is removed, fascicles are cut, and (\~5 pieces per side; \~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the substantia nigra.

Trial Locations (1)

40536

University of Kentucky, Lexington

All Listed Sponsors
lead

Craig van Horne, MD, PhD

OTHER