Actively Recruiting
Led by Craig van Horne, MD, PhD · Updated on 2025-08-14
24
Participants Needed
1
Research Sites
60 weeks
Total Duration
C
Craig van Horne, MD, PhD
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
Researchers are investigating the safety, feasibility, and clinical effects of implanting autologous peripheral nerve tissue (PNT) into specific brain areas to support motor and non-motor symptoms in patients with Parkinson's Disease (PD) undergoing deep brain stimulation (DBS) surgery. This Phase I randomized, double-blind trial focuses on comparing PNT delivery to either the nucleus basalis of Meynert (NBM) or the substantia nigra (SN), both important brain regions involved in cognitive and motor functions. The study enrolls 24 participants over three years to evaluate this "repair cell" approach in PD treatment. Participants will undergo standard DBS surgery, during which a sural nerve biopsy is taken from the ankle. Small pieces of the processed nerve tissue are then implanted bilaterally into either the NBM or SN based on random assignment. The trial monitors the surgical delivery of PNT and compares the outcomes between the two brain target groups. This procedure aims to assess the effects of PNT on brain areas affecting cognition and motor symptoms in PD. Participants will be assessed before surgery, two weeks after, and at 6, 12, and 24 months post-surgery for neurocognitive function, motor abilities, daily living activities, and quality of life. Researchers will track successful PNT implantation, study-related adverse events, and changes in cognitive and motor scales such as the Montreal Cognitive Assessment (MoCA) and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The study includes long-term follow-up to evaluate safety and clinical responses over two years after surgery.
CONDITIONS
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo deep brain stimulation (DBS) surgery during which a biopsy of the sural nerve is taken and autologous peripheral nerve tissue is implanted bilaterally into the brain.
1 surgical visit (in-person)
Duration - Up to 24 months
Participants are monitored with clinical assessments to evaluate safety and clinical responses after the surgery and implantation.
Visits at 6, 12, and 24 months for clinical assessments
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
J
Jaimie Hixson
G
Group Monitored Email
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jorge E Quintero, Monica J Chau, John T Slevin...
https://pubmed.ncbi.nlm.nih.gov/40007169Craig G van Horne, Jorge E Quintero, John T Slevin...
https://pubmed.ncbi.nlm.nih.gov/29451447Jorge E Quintero, John T Slevin, Julie A Gurwell...
https://pubmed.ncbi.nlm.nih.gov/35949912