Trials / Completed
CompletedNCT01944228
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- Male
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2013-09-17
- Last updated
- 2013-10-31
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01944228. Inclusion in this directory is not an endorsement.