---
title: Protect substantia nigra dopamine neurons
nct_id: NCT06683378
phase: PHASE1
status: RECRUITING
sponsor: Craig van Horne, MD, PhD
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06683378"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06683378"
last_fetched: "2026-05-10T14:02:43.517Z"
source: "Parkinson's Pathways (curated)"
---
# Protect substantia nigra dopamine neurons

**Goal (in five words):** Protect substantia nigra dopamine neurons

**Official Title:** Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery

**Trial ID:** [NCT06683378](https://clinicaltrials.gov/study/NCT06683378)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Craig van Horne, MD, PhD
- **Target Enrollment:** 24 participants
- **Start Date:** 2025-07-21
- **Completion Date:** 2026-12-31
- **Conditions:** Parkinson's Disease
- **Interventions:** Reparative Autologous peripheral nerve tissue
- **Intervention Types:** PROCEDURE

## Summary For Families

It aims to help the specific motor problems tied to the substantia nigra or the non-motor issues linked to the nucleus basalis of Meynert by giving local, reparative support to those brain regions. The team takes a small piece of your own peripheral nerve, usually the sural nerve, and implants that autologous tissue into the target area during your planned DBS surgery; the graft releases growth factors and supportive cells that may protect or help repair dying neurons, so it is intended to complement, not replace, levodopa or DBS. The trial is a phase 1 safety and feasibility study enrolling about 24 people. Eligible participants are age 45 to 75 with clinically established or probable Parkinsons who are already scheduled for DBS, can tolerate MRI and surgery, have an available sural nerve, and do not have dementia, prior brain surgery, or an obstructed surgical path.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Undergoing DBS
* Diagnosis of clinically established or clinically probably PD as defined by MDS criteria
* Age 45-75, inclusive
* Able to tolerate the surgical procedure
* Able to undergo all planned assessments
* Available access to the sural nerve

Exclusion Criteria:

* Any condition that would not make the subject a candidate for DBS
* Dementia diagnosis
* Previous PD surgery or intracranial surgery
* Unable to undergo an MRI
* An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert
```

## Locations (1)

- University of Kentucky, Lexington, Kentucky, United States _(37.9887, -84.4777)_
  - Jaimie Hixson — (CONTACT) — 859-323-1908 — jaimie.henderson@uky.edu

## Central Contacts

- Jaimie Hixson — (CONTACT) — 8593231908 — jaimie.henderson@uky.edu
- Group Monitored Email — (CONTACT) — nervegraft@uky.edu

---

*Canonical: https://parkinsonspathways.com/trial/NCT06683378*  
*HTML version: https://parkinsonspathways.com/trial/NCT06683378*  
*Source data: https://clinicaltrials.gov/study/NCT06683378*