Actively Recruiting
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
Led by Craig van Horne, MD, PhD · Updated on 2025-08-14
24
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
C
Craig van Horne, MD, PhD
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing DBS surgery
- Diagnosis of clinically established or clinically probable Parkinson's Disease as defined by MDS criteria
- Age between 45 and 75 years, inclusive
- Able to tolerate the surgical procedure
- Able to complete all planned assessments
- Available access to the sural nerve near the ankle
You will not qualify if you...
- Any condition that makes the participant unsuitable for DBS surgery
- Diagnosis of dementia
- Previous Parkinson's Disease or intracranial surgery
- Unable to undergo MRI scans
- Obstructed surgical path to the substantia nigra or nucleus basalis of Meynert
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
J
Jaimie Hixson
CONTACT
G
Group Monitored Email
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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