NL-OMON38643
Completed
Phase 2
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study - NoSIRS
Medtronic Inc., Cardiac Rhythm Disease Management0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Condities geassocieerd met een overmatige of ongewenste immuunrespons
- Sponsor
- Medtronic Inc., Cardiac Rhythm Disease Management
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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 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 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
Not specified
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