HealthyNCT07184190
Effects of Trancutaneous Auriculotemporal Nerve Stimulation
A study testing Trancutaneous Auriculotemporal Nerve Stimulation in people with Healthy, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
Neuromodulation works by either actively stimulating nerves, causing the alteration or modulation of nerve activity by delivering electrical agents directly to a target area. Transcutaneous auricular vagus nerve stimulation is a noninvasive therapy that has demonstrated positive effects in a wide range of conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trancutaneous Auriculotemporal Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteArgentina
- Study dates
- 26 Sep 2025to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes, aged 18 to 35 years;
- No symptoms or history of disease in the craniofacial region;
- No symptoms of chronic pain in any body region.
Who cannot join
- History of surgery, trauma to the craniofacial region or cancer;
- Systemic disease (e.g., rheumatic disease);
- Neurological and/or psychiatric disorders;
- Altered sensation (e.g., hipo or hypersensitivity);
- Current pregnancy or menstrual cycle
- Intake medication (e.g., centrally acting);
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- Prior experience with electrical stimulation treatment;
- Intense physical activity, use of stimulants and/or analgesics in the previous 24 hours;
- Acute sleep disruptions (e.g., recent sleep deprivation);
- Inability to understand the informed consent document.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Universidad del Gran Rosario
Rosario, Santa Fe Province, S2134BZH
About this study
Official title: Effects of Trancutaneous Auriculotemporal Nerve Stimulation on Nociceptive Processing. A Randomized, Double-blind, Crossover Pilot Clinical Trial.
Neuromodulation works by either actively stimulating nerves, causing the alteration or modulation of nerve activity by delivering electrical agents directly to a target area.
Transcutaneous auricular vagus nerve stimulation is a noninvasive therapy that has demonstrated positive effects in a wide range of conditions. The auricular branch of the vagus nerve is stimulated by electrical pulses in the skin of the ear (cymba conchae). Knowledge about the effects of trigeminal nerve stimulation has increased considerably in recent decades, demonstrating great potential as a therapeutic tool. However, to date, no studies have evaluated the effects of transcutaneous auriculotemporal nerve stimulation (tANS).
Therefore, the aim of this study will be to compare the effects of two types of tANS on nociceptive processing in asymptomatic volunteers.
Read the detailed description
This study will be a randomized, double-blind, crossover pilot clinical trial. Its objective is to compare the immediate effects of two types of transcutaneous auriculotemporal nerve stimulation (tANS) applied to the auricular helix on nociceptive processing in asymptomatic volunteers.
Outcome measures will include pressure pain threshold, temporal summation of pain, and conditioned pain modulation. Adverse effects and treatment tolerance will also be recorded.
Eligible participants will be randomly assigned to one of two groups:
Group 1: tANS using transcutaneous electrical nerve stimulation (TENS)
Group 2: tANS using electrical stimulation (ES)
Each intervention will be administered 72 hours apart at the University of Greater Rosario (Rosario, Argentina).
Outcomes will be assessed both before and after each treatment. All assessments will be conducted by a physical therapist blinded to group allocation.
- Conditions
- Healthy
- Being tested
- Trancutaneous Auriculotemporal Nerve Stimulation
- Keywords
- Neuromodulation, Transcutaneous nerve stimulation, Pressure Pain Threshold, Temporal Summation of Pain, Conditioned Pain Modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trancutaneous Auriculotemporal Nerve StimulationOther
Trancutaneous Auriculotemporal Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auriculotemporal Nerve Stimulation (TENS) | Experimental | The tANS (TENS) will be administered using clip electrodes placed on the auricular helix for 30 minutes per session. Stimulation parameters will be: alternating frequency to avoid tolerance; low frequency (2-10 Hz); and high frequency (50-100 Hz). The pulse width will be 125-200 μs, and the current intensity will be individually adjusted to produce a strong but non-painful sensory response. Receives: Other: Trancutaneous Auriculotemporal Nerve Stimulation |
| Transcutaneous Auriculotemporal Nerve Stimulation (EE) | Active comparator | The tANS (EE) will be administered using clip electrodes placed on the auricular helix for 30 minutes per session. Stimulation parameters will be: biphasic rectangular pulses, with a frequency between 30 and 60 Hz, a pulse width of 200 to 300 μs, a 20-second on / 20-second off duty cycle, and a 2-second ramp-up and ramp-down phase. The current intensity will be individually adjusted to produce a strong but non-painful sensory response. Receives: Other: Trancutaneous Auriculotemporal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in Pressure Pain Threshold
The Pressure Pain Threshold (PPT) will be measured through a pressure algometer in 2 different sites bilaterally; 1) temporomandibular joint and 2) thenar eminence. At each site, 3 measurements will be made with an interval of 30 seconds, and the mean will be registered. To determine the PPT, the pressure will be increased at a rate of approximately 1 kg/second and patients will be asked to raise their arm the moment the pressure begins to change to a sensation of pain, at which point, the evaluator will stop pressing. PPT values will be expressed in kg/cm2. The PPT will be determined as the arithmetic mean of the three measurements. A higher score means a better result.
Measured: Pre-intervention and post-intervention with a 72 hours washout period, between groups
Change in Temporal Summation of Pain
Temporal Summation of Pain (TSP) will be induced using a pressure algometer. For TSP, 10 consecutive pressure pulses will be elicited using the PPT (obtained before). For each pulse of the TSP procedure, the pressure will increase at a rate of 1 kg/second until the PPT is reached, where it will remain for one second before being released. The pressure pulses will be repeatedly performed with an interval between stimuli of one second. Participants will be instructed to assess the pain intensity of the first and tenth pressure pulses according to the numeric pain rating scale (NPRS). The TSP score will be obtained by subtracting the first NPRS score from the last score. The higher the TSP score, the more efficient the nociceptive signaling for the brain.
Measured: Pre-intervention and post-intervention with a 72 hours washout period, between groups
Change in Conditioned Pain Modulation
For Conditioned Pain Modulation (CPM), cold water immersion will be used as the conditioning stimulus (CS) and the PPT as the test stimulus (TS). The participant will immerse their non-dominant hand in a cold water bath at approximately 4°C (±0.5°C) until they reach their maximum pain tolerance or 2 minutes after the start of the immersion, at which point they will remove their hand. The TS will be taken before and immediately after the CS (three PPT measurements). Differences between the PPT values before and after the CS will be considered as CPM values. A greater difference in score indicates more efficient descending inhibition.
Measured: Pre-intervention and post-intervention with a 72 hours washout period, between groups
Secondary outcomes (1)
Adverse Effects And Tolerance
Participants will be asked about the presence of adverse effects immediately and 72 hours after the stimulations (e.g., itching or skin irritability at the electrode placement site) and their assessment of which stimulation was best tolerated (using the numerical pain rating scale).
Measured: Time Frame: Immediately and 72 hours after the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start26 Sep 2025
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Barone, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184190
- Sponsor's protocol ID
- 25/20
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information shared, if required, will be the Statistical Analysis Plan and Informed Consent Form.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trancutaneous Auriculotemporal Nerve Stimulation on Nociceptive Processing. A Randomized, Double-blind, Crossover Pilot Clinical Trial.
- ClinicalTrials.gov ID
- NCT07184190
- Acronym / sponsor ID
- 25/20
- Conditions
- Healthy
- Keywords
- Neuromodulation, Transcutaneous nerve stimulation, Pressure Pain Threshold, Temporal Summation of Pain, Conditioned Pain Modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromodulation works by either actively stimulating nerves, causing the alteration or modulation of nerve activity by delivering electrical agents directly to a target area.
Transcutaneous auricular vagus nerve stimulation is a noninvasive therapy that has demonstrated positive effects in a wide range of conditions. The auricular branch of the vagus nerve is stimulated by electrical pulses in the skin of the ear (cymba conchae). Knowledge about the effects of trigeminal nerve stimulation has increased considerably in recent decades, demonstrating great potential as a therapeutic tool. However, to date, no studies have evaluated the effects of transcutaneous auriculotemporal nerve stimulation (tANS).
Therefore, the aim of this study will be to compare the effects of two types of tANS on nociceptive processing in asymptomatic volunteers.
Detailed description
This study will be a randomized, double-blind, crossover pilot clinical trial. Its objective is to compare the immediate effects of two types of transcutaneous auriculotemporal nerve stimulation (tANS) applied to the auricular helix on nociceptive processing in asymptomatic volunteers.
Outcome measures will include pressure pain threshold, temporal summation of pain, and conditioned pain modulation. Adverse effects and treatment tolerance will also be recorded.
Eligible participants will be randomly assigned to one of two groups:
Group 1: tANS using transcutaneous electrical nerve stimulation (TENS)
Group 2: tANS using electrical stimulation (ES)
Each intervention will be administered 72 hours apart at the University of Greater Rosario (Rosario, Argentina).
Outcomes will be assessed both before and after each treatment. All assessments will be conducted by a physical therapist blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auriculotemporal Nerve Stimulation (TENS) | Experimental | Other: Trancutaneous Auriculotemporal Nerve StimulationThe tANS (TENS) will be administered using clip electrodes placed on the auricular helix for 30 minutes per session. Stimulation parameters will be: alternating frequency to avoid tolerance; low frequency (2-10 Hz); and high frequency (50-100 Hz). The pulse width will be 125-200 μs, and the current intensity will be individually adjusted to produce a strong but non-painful sensory response. |
| Transcutaneous Auriculotemporal Nerve Stimulation (EE) | Active comparator | Other: Trancutaneous Auriculotemporal Nerve StimulationThe tANS (EE) will be administered using clip electrodes placed on the auricular helix for 30 minutes per session. Stimulation parameters will be: biphasic rectangular pulses, with a frequency between 30 and 60 Hz, a pulse width of 200 to 300 μs, a 20-second on / 20-second off duty cycle, and a 2-second ramp-up and ramp-down phase. The current intensity will be individually adjusted to produce a strong but non-painful sensory response. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects of both sexes, aged 18 to 35 years;
- No symptoms or history of disease in the craniofacial region;
- No symptoms of chronic pain in any body region.
Key exclusion criteria (10 listed)
- History of surgery, trauma to the craniofacial region or cancer;
- Systemic disease (e.g., rheumatic disease);
- Neurological and/or psychiatric disorders;
- Altered sensation (e.g., hipo or hypersensitivity);
- Current pregnancy or menstrual cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trancutaneous Auriculotemporal Nerve StimulationTrancutaneous Auriculotemporal Nerve Stimulation | Other | Transcutaneous Auriculotemporal Nerve Stimulation (EE), Transcutaneous Auriculotemporal Nerve Stimulation (TENS) |
Primary outcome
1. Change in Pressure Pain Threshold
Time frame: Pre-intervention and post-intervention with a 72 hours washout period, between groups
The Pressure Pain Threshold (PPT) will be measured through a pressure algometer in 2 different sites bilaterally; 1) temporomandibular joint and 2) thenar eminence. At each site, 3 measurements will be made with an interval of 30 seconds, and the mean will be registered. To determine the PPT, the pressure will be increased at a rate of approximately 1 kg/second and patients will be asked to raise their arm the moment the pressure begins to change to a sensation of pain, at which point, the evaluator will stop pressing. PPT values will be expressed in kg/cm2. The PPT will be determined as the arithmetic mean of the three measurements. A higher score means a better result.
Change in Temporal Summation of Pain
Time frame: Pre-intervention and post-intervention with a 72 hours washout period, between groups
Temporal Summation of Pain (TSP) will be induced using a pressure algometer. For TSP, 10 consecutive pressure pulses will be elicited using the PPT (obtained before). For each pulse of the TSP procedure, the pressure will increase at a rate of 1 kg/second until the PPT is reached, where it will remain for one second before being released. The pressure pulses will be repeatedly performed with an interval between stimuli of one second. Participants will be instructed to assess the pain intensity of the first and tenth pressure pulses according to the numeric pain rating scale (NPRS). The TSP score will be obtained by subtracting the first NPRS score from the last score. The higher the TSP score, the more efficient the nociceptive signaling for the brain.
Change in Conditioned Pain Modulation
Time frame: Pre-intervention and post-intervention with a 72 hours washout period, between groups
For Conditioned Pain Modulation (CPM), cold water immersion will be used as the conditioning stimulus (CS) and the PPT as the test stimulus (TS). The participant will immerse their non-dominant hand in a cold water bath at approximately 4°C (±0.5°C) until they reach their maximum pain tolerance or 2 minutes after the start of the immersion, at which point they will remove their hand. The TS will be taken before and immediately after the CS (three PPT measurements). Differences between the PPT values before and after the CS will be considered as CPM values. A greater difference in score indicates more efficient descending inhibition.
1 secondary outcome
Adverse Effects And Tolerance
Time frame: Time Frame: Immediately and 72 hours after the interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. The information shared, if required, will be the Statistical Analysis Plan and Informed Consent Form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trancutaneous Auriculotemporal Nerve Stimulation in people with Healthy, run by University of Gran Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in Pressure Pain Threshold (time frame: Pre-intervention and post-intervention with a 72 hours washout period, between groups). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.