Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation (TVNS_TSP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Acute
• Intervention / Treatment: Device: TENS eco 2 Transauricular vagal nerve stimulation; Device: Sham TENS eco 2

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taras Usichenko, MD, PhD; Phone Number: +49 3834865893; Email: taras@uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • University Medicine of Greifswald
    • Contact: Taras Usichenko, MD, PhD; Email: taras@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Comparator: 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.	Device: Sham TENS eco 2; Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate (bpm)	Continuously 5 minutes during the experimental heat pain stimulation
Blood pressure	Systolic and diastolic blood pressure	4 times during 5 minutes of the experimental heat pain stimulation

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: BB 196/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data will be available of request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No