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Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study

NCT01944228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-10-31

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response.

In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide \[LPS\]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS using a minimally invasive delivery method.

Conditions

Interventions

DEVICE

Vagal Nerve Stimulation

30 minutes of vagal nerve stimulation using a catheter in the IJV

DEVICE

Sham Stimulation

Catheter placed in the IJV without stimulation

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Peter Pickkers, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944228 on ClinicalTrials.gov