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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 is a NA study that was terminated before completion, run by Northwell Health. The registered enrollment target is 47 participants.

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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.

Interventions

  • DEVICE Transcutaneous electrical auricular vagus nerve stimulation (VNS)

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2020-01-13
Est. Completion 2021-01-07
Phase NA

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT04256837

The ClinicalTrials.gov registry entry for NCT04256837 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Transcutaneous electrical auricular vagus nerve stimulation (VNS) is the first listed.

NCT04256837 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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