Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation (TVNS_TSP)

University Medicine Greifswald

Status: Unknown

Conditions: Pain, Acute

Treatments: Device: TENS eco 2 Transauricular vagal nerve stimulation; Device: Sham TENS eco 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04448990

BB 196/18

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 2 patient groups

tVNS

Experimental group

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.

Treatment:

Device: TENS eco 2 Transauricular vagal nerve stimulation

Sham

Sham Comparator group

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.

Treatment:

Device: Sham TENS eco 2