Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation
NCT ID: NCT04448990
Last Updated: 2020-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2021-05-31
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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tVNS
Stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) bilaterally at the cymba conchae of the auricles for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
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.
Sham
Same stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) to bilaterally to the earlobes for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
Sham TENS eco 2
Sham
Interventions
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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.
Sham TENS eco 2
Sham
Eligibility Criteria
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Inclusion Criteria
* at least two days free from consume of recreational drugs
* no local infection at the site of tVNS and pain stimulation
Exclusion Criteria
* abnormal skin conditions (infection, scars, psoriasis, eczema) at the site of tVNS
* contra-indications for MRI (e.g. claustrophobia, pregnancy, tattoos, metallic implants)
* history of coronary heart disease, cardiac arrhythmia, glaucoma, allergy to sulphates
19 Years
40 Years
ALL
Yes
Sponsors
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University Medicine Greifswald
OTHER
Responsible Party
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Locations
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University Medicine of Greifswald
Greifswald, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BB 196/18
Identifier Type: -
Identifier Source: org_study_id
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