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Autologous Sural Nerve Grafting for Parkinson's Disease and Multiple System Atrophy

This study is testing the safety and feasibility of a procedure called autologous sural nerve grafting. This involves taking a small piece of nerve from your ankle (sural nerve) and implanting it into a specific area of your brain called the substantia nigra. This procedure is being explored for people with Parkinson's Disease (PD) or Multiple System Atrophy (MSA). The study aims to see if this method could help repair damaged brain cells and slow disease progression. Seven participants will be enrolled, with four receiving the nerve graft and three receiving a sham surgery (a procedure that mimics the real one without the actual graft). You might be eligible if you are between 40 and 75 years old, have had PD or MSA for more than two years, and have less severe symptoms.

Study design
This is a Phase 1, double-blind study. Seven participants will be enrolled, with four receiving the experimental procedure and three receiving a sham surgery.
What's involved
Participants will undergo a biopsy of the sural nerve from their ankle. Those in the experimental arm will also have brain surgery to implant the nerve tissue.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06683365

Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies

Recruiting
PHASE1Ages 40–75InterventionalTreatment
Craig van Horne, MD, PhD
~7 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Sural Nerve Graft to the Substantia NigraSham surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Meet recruitment goal
Measured over Trial opening through 12 months

Conditions

Multiple System Atrophy
Parkinsons Disease

Explore related trials

Multiple System AtrophyParkinson Disease

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Craig van Horne, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Jaimie Hixson
[email protected]
859-323-1908
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
Disease duration greater than 2 years
Age 40-75, inclusive
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
No MDS-UPDRS Part III score \>3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
Able and willing to undergo ioflupane/SPECT
Able to tolerate the surgical procedure
Able to undergo all planned assessments
Available access to the sural nerve

Exclusion

Previous PD surgery or intracranial surgery
Ongoing major medical or psychiatric disorder incl. depression and psychosis
Other concomitant treatment with neuroleptics
Typical, nonparkinsonian syndrome ioflupane/SPECT signal
Unable to undergo an MRI
An obstructed trajectory path to the substantia nigra
Significant microvascular disease
Use of anticoagulants other than aspirin
Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.

What this trial measures

  • Meet recruitment goalTrial opening through 12 months

    Ability to recruit, enroll, and assign participants to the trial within 12 months of the trial opening.