A Phase 1 interventional study of Vagal Nerve Stimulation and Sham Stimulation in Inflammation, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-31.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Phase 1, Interventional, and Basic science
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 2,436 interventional studies indexed under Inflammation.
Browse Inflammation studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 minutes of vagal nerve stimulation using a catheter in the IJV
Device: Vagal Nerve Stimulation
Catheter placed in the IJV without stimulation
Device: Sham Stimulation
30 minutes of vagal nerve stimulation using a catheter in the IJV
Catheter placed in the IJV without stimulation
Plasma TNF-α concentration
Plasma TNF-α concentration after LPS administration (Area Under Curve); comparison of subjects treated with tVNS versus sham tVNS.
Time frame: 24 hours
Plasma concentrations of pro-inflammatory and anti-inflammatory cytokines
Plasma concentrations of pro-inflammatory and anti-inflammatory cytokines (including TNF-α, IL 6, IL 1RA, IL 10) up to 24 h after LPS injection to document the immune response up to 24 hrs; comparison of subjects treated with tVNS versus sham tVNS.
Time frame: up to 24 h
Leukocyte responses to ex vivo stimulation
Leukocyte responses to ex vivo stimulation with inflammatory stimuli and leukocyte phagocytosis capacity up to 24 hrs; comparison of subjects treated with tVNS versus sham tVNS
Time frame: up to 24 hrs
Endotoxemia-related clinical symptoms
Endotoxemia-related clinical symptoms, hemodynamic parameters, and temperature up to 24 hrs; comparison of subjects treated with tVNS versus sham tVNS.
Time frame: up to 24 hrs
Endotoxemia-induced circulating leukocyte changes
Endotoxemia-induced circulating leukocyte changes up to 24 hrs; comparison of subjects treated with tVNS versus sham tVNS.
Time frame: up to 24 hrs
Autonomic nervous system activity
Autonomic nervous system activity measured by heart rate variability up to 24 hrs; comparison of subjects treated with tVNS versus sham tVNS.
Time frame: up to 24 hrs
Tolerability of acute side effects of tVNS
Tolerability of acute side effects of tVNS. Subject feedback during VNS.
Time frame: Acute 30 min stimulation
Ease of tVNS delivery
Perception of delivery difficulty.
Time frame: acute interoperative
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure