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Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation

NCT04448990 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-06-26

No results posted yet for this study

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

  • Pain, Acute

Interventions

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

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2023-04-30
Completion
2023-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448990 on ClinicalTrials.gov