Trials / Unknown
UnknownNCT04448990
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- University Medicine Greifswald · Academic / Other
- Sex
- All
- Age
- 19 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TENS eco 2 Transauricular vagal nerve stimulation | Auricular electrical stimulation will be applied bilaterally using Transcutaneous Electrical Nerve Stimulation device TENS eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany). tVNS will be applied bilaterally using electrical square impulses delivered in blocks of 9 impulses with a frequency of 100 Hz and a pulse width of 200 μs emitted twice per second resulting in mixed frequency pattern of 100 Hz/2 Hz with the current intensity, that will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. |
| DEVICE | Sham TENS eco 2 | Sham |
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2023-04-01
- Completion
- 2023-08-01
- First posted
- 2020-06-26
- Last updated
- 2020-06-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04448990. Inclusion in this directory is not an endorsement.