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NCT06683378 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT06683378 is a Phase 1 study of Parkinson's Disease that is actively recruiting participants, run by Craig van Horne, MD, PhD. The registered enrollment target is 24 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06683378, a Phase 1 study of Parkinson's Disease, is actively recruiting participants, sponsored by Craig van Horne, MD, PhD.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

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 Studied

Parkinson's Disease

Interventions

  • PROCEDURE Reparative Autologous peripheral nerve tissue

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-07-21
Est. Completion 2028-02-28
Phase Phase 1

Sponsor

Craig van Horne, MD, PhD

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06683378

The ClinicalTrials.gov registry entry for NCT06683378 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (96% lower). The listed sponsor is Craig van Horne, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Reparative Autologous peripheral nerve tissue is the first listed.

NCT06683378 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT06683378 about?

NCT06683378 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06683378?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-07-21. Estimated completion is 2028-02-28.

What conditions does trial NCT06683378 study?

This clinical trial studies the following conditions: Parkinson's Disease.

What interventions are being tested in trial NCT06683378?

The interventions under investigation include: Reparative Autologous peripheral nerve tissue (PROCEDURE).

Who is sponsoring clinical trial NCT06683378?

This trial is sponsored by Craig van Horne, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06683378 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.