The primary objective of this study is to determine the anti-inflammatory potential of mechanical auricular Vagus nerve stimulation in healthy humans.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To obtain insight into the Vagus *tone* or the amount of Vagus nerve signals,
heart rate variability will be determined. In addition, blood will be obtained
before and at 0.5, 2, 5 and 24 hours after Vagus nerve stimulation for *ex
vivo* tests evaluating a number of inflammatory responses.
Secondary outcome
Not applicable.
Background summary
Many common diseases are now recognized as *inflammatory disorders*. The
pathology of these diseases, among which diverse pathological conditions such
as rheumatoid arthritis, inflammatory bowel disease, pancreatitis and fulminant
sepsis prominently feature, are considered to be mediated for a large part by
uncontrolled inflammation. As a consequence, current therapies directed against
these diseases at least in part rely on the administration of anti-inflammatory
compounds. The nervous system, through the Vagus nerve, can downregulate
inflammation in experimental animals in vivo by an interaction of
acetylcholine, the principal neurotransmitter of the Vagus nerve, with
macrophage cholinergic nicotinic acetylcholine receptors.
Study objective
The primary objective of this study is to determine the anti-inflammatory
potential of mechanical auricular Vagus nerve stimulation in healthy humans.
Study design
20 healthy male subjects will be studied on two occasions (balanced assignment)
separated by at least three weeks. On one occasion subjects will undergo
mechanical auricular Vagus nerve stimulation, whereas on the other occasion the
Vagus nerve will not be stimulated. Vagus nerve stimulation will be
administered using a commercially available oscillatory device at the right
cymba conchae (located posterior to the crus of the helix in the frontal part
of the ear with 100 % Vagus nerve innervation).
Intervention
Mechanical stimulation of the nervus Vagus in the right cymba conchae.
Study burden and risks
Vagus nerve stimulation is associated with a small risk for bradycardia.
Venipunctures are associated with a small risk for a hematoma.
Meibergdreef 9
1105AZ Amsterdam
Nederland
Meibergdreef 9
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Male subjects between 18 and 50 years of age.
2. No clinically significant findings during physical examination and hematological and biochemical screening.
3. Normal electrocardiogram.
4. Able to communicate well with the investigator and to comply with the requirements of the study.
5. No medication.
6. Written informed consent.
Exclusion criteria
1. Known diseases, including previously documented cardiac arrhythmias.
2. A history of smoking within the last six months, or regular consumption of greater than three Units of alcohol per day.
3. Administration of any investigational drug within 30 days of study initiation.
5. Donation of blood within 60 days, or loss greater than 400 ml of blood within 12 weeks of study initiation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16944.018.07 |