NCT01944228CompletedPhase 1
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
Medtronic Cardiac Rhythm and Heart Failure2 sites in 1 country22 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Plasma TNF-α concentration
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Plasma TNF-α concentration
Time Frame: 24 hours
Plasma TNF-α concentration after LPS administration (Area Under Curve); comparison of subjects treated with tVNS versus sham tVNS.
Secondary Outcomes
- Plasma concentrations of pro-inflammatory and anti-inflammatory cytokines(up to 24 h)
- Endotoxemia-related clinical symptoms(up to 24 hrs)
- Autonomic nervous system activity(up to 24 hrs)
- Tolerability of acute side effects of tVNS(Acute 30 min stimulation)
- Endotoxemia-induced circulating leukocyte changes(up to 24 hrs)
- Ease of tVNS delivery(acute interoperative)
- Leukocyte responses to ex vivo stimulation(up to 24 hrs)
Investigators
Study Sites (2)
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