Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
16
Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve.
Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
Feinstein Institute
Manhasset, New York, United States
Lipopolysaccharide stimulated levels of TNF in whole blood.
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of TNF produced by the cells in the whole blood after 4 hours of incubation will be measured.
Time frame: 4 hours
Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 that are produced by the cells in the whole blood after 4 hours of incubation will be measured.
Time frame: 4 hours
Percentage of subjects with treatment emergent adverse events
The percentage of participants with treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
Time frame: 1 hour
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