Tonic Pain and Transauricular Vagal Nerve Stimulation

NCT ID: NCT07325058

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Experimental Pain in Healthy Human Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Burst-taVNS, active-control (electrical stimulation of the earlobe) or sham will be administred to the participant on one of the three visits. Order of stimulation condition will be randomly selected and counter-balanced across participants (minding sex at birth).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Electrodes for the different stimulation conditions will be applied during all three visits regardless of which stimulation is active. Wiring of the electrodes is the same but labelled with 'A' or 'B'. Corresponding stimulation condition will not be known to the experimenter (that is also analyzing the data) until after data analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

taVNS

Bursts of 25Hz occuring for 3.4sec every 29.4sec for 40min.

Group Type EXPERIMENTAL

taVNS

Intervention Type DEVICE

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

Earlobe Stimulation

Bursts of 25Hz occuring for 3.4sec every 29.4sec for 40min.

Group Type ACTIVE_COMPARATOR

Earlobe Stimulation

Intervention Type DEVICE

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

Sham

No stimulation.

Group Type PLACEBO_COMPARATOR

Sham (No Treatment)

Intervention Type DEVICE

Circular surface adhesive electrodes will be placed on either facet of the earlobe. No current will pass through the electrodes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

taVNS

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

Intervention Type DEVICE

Earlobe Stimulation

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

Intervention Type DEVICE

Sham (No Treatment)

Circular surface adhesive electrodes will be placed on either facet of the earlobe. No current will pass through the electrodes.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laura De Herde

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center For Neuroplasticity and Pain

Aalborg, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laura M.R. De Herde

Role: primary

004593889540

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-20230022-5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of taVNS on Fibromyalgia Pain
NCT06193317 NOT_YET_RECRUITING NA
taVNS Treatment for Fibromyalgia
NCT04777500 NOT_YET_RECRUITING NA
taVNS Cold Pressor
NCT05254080 COMPLETED NA
Learning and Ear Stimulation
NCT04812015 COMPLETED NA