Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study - Transvenous VNS Immune Response

Medtronic Inc.0 sitesFebruary 6, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 6, 2013

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Medtronic Inc.

•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
•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