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Clinical Trials in Denmark / NCT07325058
Recruiting Not applicable

Tonic Pain and Transauricular Vagal Nerve Stimulation

NCT07325058 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aalborg University
Phase
Not applicable
Started
2025-12-18
Last updated
2026-01-08

Condition(s) studied

Experimental Pain in Healthy Human Subjects

Investigational drug(s) / intervention(s)

taVNSEarlobe StimulationSham (No Treatment)

taVNS: Two-headed ball-point electrode which is placed in the concha cymba.

Earlobe Stimulation: Circular urface adhering electrodes will be attached to either facet of the earlobe.

Sham (No Treatment): Circular surface adhesive electrodes will be placed on either facet of the earlobe. No current will pass through the electrodes.

Study summary

This study aims to explore the effect of burst-taVNS (electric stimulation of the concha cymba) on tonic (capsaicin-induced skin pain) and acute (pressure pain sensitivity) experimental pain and cardioception. Primary outcomes include pain intensity. Secondary outcomes include sensory thresholds, resting heart rate (EKG), pupillary measurements and conditioned pain modulation.

Eligibility

Sex
ALL
Min age
16 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy * Speak and understand English * 18-60 years old. Exclusion Criteria: * Pregnant and/or breastfeeding * Regular use of cannabis, opioids or other drugs * Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.) * Current regular (once or more a week) use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs) * Recent history of acute pain particularly in the lower limbs * Abnormally disrupted sleep in 24 hours preceding experiment * Contraindications to electric stimulation application (history of epilepsy, metal implants in head or jaw, etc.) * Lack of ability to cooperate * Contraindications for capsaicin including an intolerance chili consumption and burns or wounds to the application site.

Primary outcome measure(s)

  • Pain Intensity — From when capsaicin is applied to the end of the experiment in 5 min intervals.
    Capaisin is a topically administered tonic pain model. Stemming from its chilly-origin, pain induced ressembels heat/light burning sensation which increases within 20minute of application to the forearm, before it plateaus. Associated pain can be stopped immediately by applying ice/cold water. Participants will be asked to rate (using a scale from 0 denoting no pain, to 10 denoting maximal pain) the intensity of the pain in 5 min time intervals.

Trial sites (1)

FacilityCityRegionStatus
Center For Neuroplasticity and Pain Aalborg Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07325058 on ClinicalTrials.gov ↗ ← All trials in Denmark