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NCT01833364 · ClinicalTrials.gov registry record · NA
Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation
A NA study, sponsored by Craig van Horne, MD, PhD.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01833364: Completed NA study, sponsored by Craig van Horne, MD, PhD.
NCT01833364 is a NA study that has completed, run by Craig van Horne, MD, PhD. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01833364, a NA study, has completed, sponsored by Craig van Horne, MD, PhD.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would promote the development of a new treatment for PD in which patients are able to provide their own tissue as a source of a supportive environment for the injured and dying cells and thereby possibly stopping the progression of the illness or even improve the symptoms of PD. The purpose of this research is to gather information on the safety and feasibility of nerve graft implantation is. The results of this study will be shared with the University of Kentucky, Center for Clinical and Translational Science (group providing financial support for the study) and other federal agencies, if required. The overall goal of this research is to develop a novel, regenerative treatment strategy for idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to patients.
Primary Outcome
All Adverse events will be collected from the time subject signs the consent to the time they complete study visit 12 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 STN. In addition, MRI imaging of the graft site within the substantia nigra will be compared to the contralateral, non-grafted site.
Interventions
- PROCEDURE Implantation of the Peripheral Nerve Graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT01833364 record still lists
NCT01833364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Implantation of the Peripheral Nerve Graft is the first listed.
NCT01833364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01833364 about?
NCT01833364 is a clinical study titled "Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation". By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would promote the development of a new treatment for PD in which patients are able to provide their own tissue as a source of a supportive enviro...
What is the current status of trial NCT01833364?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2013-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01833364?
The interventions under investigation include: Implantation of the Peripheral Nerve Graft (PROCEDURE).
Who is sponsoring clinical trial NCT01833364?
This trial is sponsored by Craig van Horne, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01833364's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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