Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation

NCT04448990 | Unknown

• 1 other identifier: BB 196/18
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart rate

  Continuously 5 minutes during the experimental heat pain stimulation

• Blood pressure

  4 times during 5 minutes of the experimental heat pain stimulation

Study Arms (2)

tVNS

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

TENS eco 2 Transauricular vagal nerve stimulation DEVICE

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.

tVNS

Sham TENS eco 2 DEVICE

Sham

Sham

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Taras Usichenko, MD, PhD

CONTACT

+49 3834865893; taras@uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Real tVNS will be applied using pre-defined characteristics of tVNS device to cymba conchae of the auricle, sham procedure will be the same, however applied to tubule of the auricle
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two periods (real and sham tVNS) randomized crossover investigation in healthy volunteers

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: May 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

DE (1)