Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
NCT ID: NCT01944228
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2013-08-31
2013-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Vagal Nerve Stimulation
30 minutes of vagal nerve stimulation using a catheter in the IJV
Vagal Nerve Stimulation
30 minutes of vagal nerve stimulation using a catheter in the IJV
Sham stimulation
Catheter placed in the IJV without stimulation
Sham Stimulation
Catheter placed in the IJV without stimulation
Interventions
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Vagal Nerve Stimulation
30 minutes of vagal nerve stimulation using a catheter in the IJV
Sham Stimulation
Catheter placed in the IJV without stimulation
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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.
18 Years
35 Years
MALE
Yes
Sponsors
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Radboud University Medical Center
OTHER
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Pickkers, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
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References
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Kox M, van Eijk LT, Verhaak T, Frenzel T, Kiers HD, Gerretsen J, van der Hoeven JG, Kornet L, Scheiner A, Pickkers P. Transvenous vagus nerve stimulation does not modulate the innate immune response during experimental human endotoxemia: a randomized controlled study. Arthritis Res Ther. 2015 Jun 7;17(1):150. doi: 10.1186/s13075-015-0667-5.
Other Identifiers
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2012-005687-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NoSIRS Study
Identifier Type: -
Identifier Source: org_study_id