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NCT02369003 · ClinicalTrials.gov registry record · Phase 1

Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS

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

Active
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT02369003: Active Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.

NCT02369003 is a Phase 1 study of Parkinson's Disease that is active but no longer recruiting, run by Craig van Horne, MD, PhD. The registered enrollment target is 70 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02369003, a Phase 1 study of Parkinson's Disease, is active but no longer recruiting, sponsored by Craig van Horne, MD, PhD.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons. Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.

Primary Outcome

Safety and Tolerability of Nerve Graft Implantation. Adverse events will be collected in order to measure the safety and tolerability of the grafting procedure. Adverse events will be documented and compared to the known and reported adverse events of DBS of Subthalamic Nucleus (STN) or internal globus pallidus (GPi).

Conditions Studied

Interventions

  • PROCEDURE Autologous Peripheral Nerve Graft

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2015-02
Est. Completion 2027-09
Phase Phase 1
Craig van Horne, MD, PhD

5 total trials

What the registry record for NCT02369003 still lists

NCT02369003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Autologous Peripheral Nerve Graft is the first listed.

NCT02369003 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT02369003 about?

NCT02369003 is a clinical study titled "Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS". This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation...

What is the current status of trial NCT02369003?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2015-02. Estimated completion is 2027-09.

What conditions does trial NCT02369003 study?

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

What interventions are being tested in trial NCT02369003?

The interventions under investigation include: Autologous Peripheral Nerve Graft (PROCEDURE).

Who is sponsoring clinical trial NCT02369003?

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

Where is trial NCT02369003 being conducted?

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

Similar trials for Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02369003's enrollment target sits among peer trials

70 68th of 158 higher than 91 of 158 other Parkinson's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02369003, the US trial registry maintained by the National Library of Medicine. NCT02369003 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.