Recruiting · registry status

Adding a person’s own nerve tissue during brain stimulation surgery

Researchers test the safety and practicality of placing a person’s own nerve tissue into the brain during planned Parkinson’s surgery.

Testing a treatment or activity · Study reference: NCT06683378

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Looking for volunteers

Start (reported actual date): 2025-07-21
Main measurements finished (planned): 2028-12-31
Study finished (planned): 2030-05-28

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 45 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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

Full study name & original research details

Official study 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

Short title used by the registry

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

Original description

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 reported: Parkinson's Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT06683378 ↗ — RECRUITING; checked 2026-10-11

Study type: Interventional
Interventions: Reparative Autologous peripheral nerve tissue
Phases: PHASE1
Sponsor: Craig van Horne, MD, PhD
Start date reported by registry: 2025-07-21 (actual)

Registry updated: 2026-08-31 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Jaimie Hixson · 8593231908 · jaimie.henderson@uky.edu

Group Monitored Email · nervegraft@uky.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Kentucky

Lexington, Kentucky, United States

Recruiting

Jaimie Hixson · 859-323-1908 · jaimie.henderson@uky.edu

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.