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Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation (TVNS_TSP)

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TENS eco 2 Transauricular vagal nerve stimulation
Sham TENS eco 2
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Medicine of Greifswald

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tVNS

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Heart rate
Heart rate (bpm)
Blood pressure
Systolic and diastolic blood pressure

Full Information

First Posted
June 23, 2020
Last Updated
June 25, 2020
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04448990
Brief Title
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation
Acronym
TVNS_TSP
Official Title
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two periods (real and sham tVNS) randomized crossover investigation in healthy volunteers
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tVNS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS eco 2 Transauricular vagal nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham TENS eco 2
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Unpleasantness of pain
Description
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).
Time Frame
Continuously 5 minutes during the experimental heat pain stimulation
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate (bpm)
Time Frame
Continuously 5 minutes during the experimental heat pain stimulation
Title
Blood pressure
Description
Systolic and diastolic blood pressure
Time Frame
4 times during 5 minutes of the experimental heat pain stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taras Usichenko, MD, PhD
Phone
+49 3834865893
Email
taras@uni-greifswald.de
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, PhD
Email
taras@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be available of request

Learn more about this trial

Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation

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