Effects of electrical stimulation of a nerve in the neck on inflammatio
- Conditions
- Possible future indications: inflammatory conditions in generalTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-005687-97-NL
- Lead Sponsor
- Medtronic Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
1.Written informed consent to participate in this trial
2.Male subjects aged 18 to 35 years inclusive
3.Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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, in particular
•An implant that in the opinion of the investigator may make invasive proceedures 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 frequent 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the effect of transvenous vagus nerve stimulation (tVNS) on the innate immune response elicited by endotoxin administration in healthy volunteers up to 24 hours after stimulation.;Secondary Objective: •Determine effects of transvenous vagus nerve stimulation on autonomic nervous system activity up to 24 hours after stimulation <br>•Determine effects of transvenous vagus nerve stimulation on ethylene and NO concentration in exhaled breath up to 24 hours after stimulation<br>•Determine tolerability of acute side effects of transvenous vagus nerve stimulation <br>•Determine ease and safety of transvenous vagus nerve stimulation delivery<br>;Primary end point(s): Plasma TNF-a concentration after LPS administration (Are Under Curve); comparison of subjects treated with tVNS versus sham tVNS. ;Timepoint(s) of evaluation of this end point: 0, 30, 60, 90, 120, 180, 240, 360, 480 minutes and 24 hours after endotoxin administration
- Secondary Outcome Measures
Name Time Method