Vagus Nerve Stimulation in Healthy Humans
- Conditions
- inflammationinflammatory diseases100179691000381610004018
- Registration Number
- NL-OMON31096
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To obtain insight into the Vagus *tone* or the amount of Vagus nerve signals,<br /><br>heart rate variability will be determined. In addition, blood will be obtained<br /><br>before and at 0.5, 2, 5 and 24 hours after Vagus nerve stimulation for *ex<br /><br>vivo* tests evaluating a number of inflammatory responses. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>