A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 21, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

February 28, 2028

Conditions
Parkinson's Disease
Interventions
PROCEDURE

Reparative Autologous peripheral nerve tissue

"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 nucleus basalis of Meynert (NBM) or substantia nigra (SN)."

Trial Locations (1)

40536

RECRUITING

University of Kentucky, Lexington

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Craig van Horne, MD, PhD

OTHER