Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study (NoSIRS)
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About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
- Written informed consent to participate in this trial
- Male subjects aged 18 to 35 years inclusive
- Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
Exclusion criteria
- Use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day
- Smoking
- Use of caffeine, or alcohol or within 1 day prior to profiling day
- Previous participation in a trial where LPS was administered
- Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day
- Participation in another clinical trial within 3 months prior to profiling day.
- History, signs or symptoms of cardiovascular disease
- An implant that in the opinion of the investigator may make invasive procedures risky for the subject due to the increased risks associated with a possible infection.
- Subject has an implanted active cardiac device (ICD, IPG and/or CRT)
- Implanted active neurostimulation device
- Subject has internal jugular vein that cannot be accessed
- History of vaso-vagal collapse or of orthostatic hypotension
- History of atrial or ventricular arrhythmia
- Resting pulse rate ≤45 or ≥100 beats / min
- Hypertension (RR systolic >160 or RR diastolic >90)
- Hypotension (RR systolic <100 or RR diastolic <50)
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
- Subject is diagnosed with epilepsy or history of seizures
- Renal impairment: plasma creatinine >120 µmol/L
- Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L
- Coagulation abnormalities: APTT or PT > 1.5 times the reference range
- History of asthma
- Immuno-deficiency
- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 2 weeks before profiling day
- Known or suspected of not being able to comply with the trial protocol
- Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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