Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation

Pain, Acute Clinical Trial

— TVNS_TSP  

Official title:

Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04448990
• Other study ID #: BB 196/18
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: August 2023

Study information

• Verified date: June 2020
• Source: University Medicine Greifswald
• Contact: Taras Usichenko, MD, PhD
• Phone: +49 3834865893
• Email: taras[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: August 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy volunteers aged 18-45 years old, who have given informed consent

• at least two days free from consume of recreational drugs

• no local infection at the site of tVNS and pain stimulation

Exclusion Criteria:

• psychiatric disorders

• 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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

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.
• Sham TENS eco 2
Sham

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unpleasantness of pain	perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain).	Continuously 5 minutes during the experimental heat pain stimulation
Secondary	Heart rate	Heart rate (bpm)	Continuously 5 minutes during the experimental heat pain stimulation
Secondary	Blood pressure	Systolic and diastolic blood pressure	4 times during 5 minutes of the experimental heat pain stimulation