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NCT04256837: VNS-KTx
Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients
NA trial testing Transcutaneous electrical auricular vagus nerve stimulation (VNS) in Vagus Nerve Stimulation in 47 participants. Terminated before completion.
7 January 2021
Quick facts
| Lead sponsor | Northwell Health |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 47 |
| Start date | 13 January 2020 |
| Primary completion | 7 January 2021 |
| Estimated completion | 7 January 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcutaneous electrical auricular vagus nerve stimulation (VNS)
Conditions studied
- Vagus Nerve Stimulation — all drugs for Vagus Nerve Stimulation →
Sponsor
Northwell Health — full company profile →
Who can join
18 and older, any sex, with Vagus Nerve Stimulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical perspectives on vagus nerve stimulation: present and future.
Goggins E, Mitani S, Tanaka S. · · 2022 · cited 54× · PMID 35536161 · DOI 10.1042/cs20210507
Verify or expand the search:
- PubMed search for NCT04256837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vagus Nerve Stimulation
Currently open trials in the same condition.
- NCT07118956 — Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease · NA · recruiting
- NCT06421051 — Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients. · NA · recruiting
- NCT06421077 — Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients · NA · recruiting
- NCT06421090 — Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients · NA · recruiting
- NCT05680337 — Auricular Vagus Stimulation and Heart Rate Variability · NA · recruiting
Other Northwell Health trials
Trials by the same sponsor.
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- NCT07254091 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer · EARLY_PHASE1 · recruiting
- NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
- NCT07193862 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Meta · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04256837 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwell Health
- Last refreshed: 14 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04256837.
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