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Recruiting NCT07325058

Tonic Pain and Transauricular Vagal Nerve Stimulation

No phase Interventional Experimental Pain in Healthy Human Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: taVNS, Earlobe Stimulation, Sham (No Treatment).
Who it may be relevant to
Registry conditions: Experimental Pain in Healthy Human Subjects. Basic parameters: 16 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Exploration of the Effect, and Their Duration, of Different Frequency Transcutaneous Auricular Vagal Nerve Stimulation on Sensory Perception.

Overview

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.

Detailed description

Across 3 visits, each lasting around 2.5hours, burst-taVNS (electrical stimulation of the concha cymba) will be compared to active-control (electrircal stimulation of the earlobe) and sham (no current) stimulation, two gold-standard controls. Assessments of outcomes will occur before capsaicin application and before, twice during and after electrical ear stimulation.

Interventions

  • Device taVNS
    Two-headed ball-point electrode which is placed in the concha cymba.
  • Device Earlobe Stimulation
    Circular urface adhering electrodes will be attached to either facet of the earlobe.
  • Device Sham (No Treatment)
    Circular surface adhesive electrodes will be placed on either facet of the earlobe. No current will pass through the electrodes.

Primary outcome measures

  • Pain Intensity [Time frame: From when capsaicin is applied to the end of the experiment in 5 min intervals.]
Secondary outcome measures (6)
  • Pressure Pain Detection Threshold [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Conditioned Pain Modulation Effect [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Pressure Pain Perception [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Pupillary Light Reflex [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Electrocardiography [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]
  • Cardioception Accuracy [Time frame: Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Center For Neuroplasticity and Pain — Aalborg

Identifiers

NCT: NCT07325058 · N-20230022-5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗