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NCT04256837 · ClinicalTrials.gov registry record · NA
Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients
A NA study, sponsored by Northwell Health.
- Terminated
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT04256837: Clinical Trial NA study, sponsored by Northwell Health.
NCT04256837 is a NA study that was terminated before completion, run by Northwell Health. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04256837, a NA study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
Kidney transplantation entails the implantation of a live or deceased organ into a recipient. As a result of this event, there is an inflammatory response in the recipient elicited by the transplanted organ. At the present time, immunosuppressive treatments are routinely used to avoid rejection of the transplanted organ. Although effective in this goal, there is currently an unmet need to develop new strategies to control the innate inflammatory responses and to reduce the injury caused to the organs being transplanted. The investigators propose a novel approach to the management of this inflammatory response. The investigators will explore the "cholinergic anti-inflammatory pathway" as a potential target, a pathway first characterized in the basic science laboratories of the Feinstein Institute for Medical Research. In short, the vagus nerve activates the splenic nerve which activates choline acetyltransferase expressing T cells in the spleen. Stimulation of the alpha7 nicotinic acetylcholine receptor (alpha7nAChR) on macrophages by acetylcholine reduces production of multiple pro-inflammatory cytokines. Currently, vagus nerve stimulation is used to treat a number of human diseases, including epilepsy, depression and migraine headaches. Many of these treatments activate the vagus nerve non-invasively by stimulating a branch of the vagus that innervates the ear. In this study, the investigators will stimulate this branch of the vagus nerve, and look for changes in inflammatory markers in the blood of kidney transplant recipients of both live and deceased donors. Successful completion of this study will allow for future studies in organ transplant recipients.
Primary Outcome
The present study will measure systemic cytokines IL-1, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL-17, IL-22, IL-23, TNF, IFN-gamma, HMGB1, TGF-beta, GM-CSF, CXCL8, G-CSFas well as complement 1-9 in the blood of kidney transplant recipients who have undergone transcutaneous auricular electrical vagus nerve stimulation.
Interventions
- DEVICE Transcutaneous electrical auricular vagus nerve stimulation (VNS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2021-01-07 |
| Phase | NA |
Why NCT04256837 stopped before completion
NCT04256837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous electrical auricular vagus nerve stimulation (VNS) is the first listed.
NCT04256837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04256837 about?
NCT04256837 is a clinical study titled "Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients". Kidney transplantation entails the implantation of a live or deceased organ into a recipient. As a result of this event, there is an inflammatory response in the recipient elicited by the transplanted organ. At the present time, immunosuppressive treatments are routinely used to avoid rejection of ...
What is the current status of trial NCT04256837?
This trial is currently terminated. It is a NA study. The enrollment target is 47 participants. The study started on 2020-01-13. Estimated completion is 2021-01-07.
What interventions are being tested in trial NCT04256837?
The interventions under investigation include: Transcutaneous electrical auricular vagus nerve stimulation (VNS) (DEVICE).
Who is sponsoring clinical trial NCT04256837?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04256837's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 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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