Actively Recruiting
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Led by Craig van Horne, MD, PhD · Updated on 2026-04-01
7
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
Sponsors
C
Craig van Horne, MD, PhD
Lead Sponsor
U
University of Kentucky CCTS
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.
CONDITIONS
Official Title
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of clinically established or probable Parkinson's disease or Multiple System Atrophy as defined by MDS criteria
- Disease duration longer than 2 years
- Age between 40 and 75 years, inclusive
- MDS-Unified Parkinson's Disease Rating Scale Part III score between 20 and 35 points off medication for Parkinson's disease, or UMSARS score less than or equal to 30 points off medication for Multiple System Atrophy
- No MDS-UPDRS Part III score greater than 3 on specific motor items while off medication
- Able and willing to undergo ioflupane/SPECT imaging
- Able to tolerate the surgical procedure
- Able to complete all planned assessments
- Accessible sural nerve for biopsy
You will not qualify if you...
- Previous Parkinson's disease surgery or any intracranial surgery
- Ongoing major medical or psychiatric disorders including depression and psychosis
- Treatment with neuroleptic medications
- Typical nonparkinsonian syndrome on ioflupane/SPECT imaging
- Unable to undergo MRI
- Obstructed path to substantia nigra for surgery
- Significant microvascular disease
- Use of anticoagulants other than aspirin
- Female who is pregnant, breastfeeding, or of child-bearing potential not using birth control during the study
- Decline in consent capacity before surgery as determined by neuropsychological exam
AI-Screening
AI-Powered Screening
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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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