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Behavioural Intervention

Transcutaneous electrical auricular vagus nerve stimulation (VNS) for Vagus Nerve Stimulation (VNS-KTx Trial)

N/A

Waitlist Available

Led By Ernesto P Molmenti, MD PhD MBA

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Kidney transplant recipients of both live and deceased donors

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

VNS-KTx Trial Summary

This trial will explore whether or not non-invasive vagus nerve stimulation can help reduce inflammation in kidney transplant recipients, potentially lessening the need for immunosuppressive treatments.

VNS-KTx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VNS-KTx Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Levels of blood inflammatory cytokines in kidney transplant recipients after transcutaneous auricular electrical vagus nerve stimulation.

VNS-KTx Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: VNS - Live donor kidney recipients.Experimental Treatment1 Intervention

Live donor kidney recipients. VNS will be applied for 5 minutes prior to start of surgery. The device to be used for VNS will include a handheld electrical pulse generator and a pair of electrodes to be placed at the left ear for stimulation, targeting the auricular branch of the vagus nerve which innervates the skin overlying the cymba conchae of the ear canal.

Group II: VNS - Deceased donor kidney recipients.Experimental Treatment1 Intervention

Deceased donor kidney recipients. VNS will be applied for 5 minutes prior to start of surgery. The device to be used for VNS will include a handheld electrical pulse generator and a pair of electrodes to be placed at the left ear for stimulation, targeting the auricular branch of the vagus nerve which innervates the skin overlying the cymba conchae of the ear canal.

Group III: sham VNS - Live donor kidney recipients.Placebo Group1 Intervention

Live donor kidney recipients. As above, but without applying any VNS

Group IV: sham VNS - Deceased donor kidney recipients.Placebo Group1 Intervention

Deceased donor kidney recipients. As above, but without applying any VNS

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,996 Total Patients Enrolled

Ernesto P Molmenti, MD PhD MBAPrincipal InvestigatorNorthwell Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored for this clinical research project?

"Agreed, the information on clinicaltrials.gov indicates that this medical trial is actively enrolling individuals. This research initiative was first posted in January 13th 2020 and recently modified on October 27th 2020; it aims to recruit 40 participants from a single location."

Answered by AI

Are there any open vacancies in this research effort?

"Affirmative, the information on clinicaltrials.gov demonstrates that this research trial is currently recruiting individuals for participation. It was first published in January 13th 2020 and recently modified October 27th 2020. The team needs 40 volunteers from a single site."

Answered by AI

Recent research and studies

NatureJournal

Nicotinic Acetylcholine Receptor Α7 Subunit Is an Essential Regulator of Inflammation

Wang, Hong, Man Yu, Mahendar Ochani, Carol Ann Amella, Mahira Tanovic, Seenu Susarla, Jian Hua Li, et al.. 2002. “Nicotinic Acetylcholine Receptor Α7 Subunit Is an Essential Regulator of Inflammation”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature01339.

ScienceJournal

Acetylcholine-synthesizing T Cells Relay Neural Signals in a Vagus Nerve Circuit

Rosas-Ballina, Mauricio, Peder S. Olofsson, Mahendar Ochani, Sergio I. Valdés-Ferrer, Yaakov A. Levine, Colin Reardon, Michael W. Tusche, et al.. 2011. “Acetylcholine-synthesizing T Cells Relay Neural Signals in a Vagus Nerve Circuit”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1209985.

Nature MedicineJournal

Cholinergic Agonists Inhibit HMGB1 Release and Improve Survival in Experimental Sepsis

Wang, Hong, Hong Liao, Mahendar Ochani, Marilou Justiniani, Xinchun Lin, Lihong Yang, Yousef Al-Abed, et al.. 2004. “Cholinergic Agonists Inhibit HMGB1 Release and Improve Survival in Experimental Sepsis”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm1124.

NatureJournal