Effects of Trancutaneous Auriculotemporal Nerve Stimulation

NCT ID: NCT07184190

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-26
• Study Completion Date: 2025-11-14

Brief 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. 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transcutaneous Auriculotemporal Nerve Stimulation (TENS)

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.

Group Type: EXPERIMENTAL

Trancutaneous Auriculotemporal Nerve Stimulation

Intervention Type: OTHER

Trancutaneous Auriculotemporal Nerve Stimulation

Transcutaneous Auriculotemporal Nerve Stimulation (EE)

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.

Group Type: ACTIVE_COMPARATOR

Trancutaneous Auriculotemporal Nerve Stimulation

Intervention Type: OTHER

Trancutaneous Auriculotemporal Nerve Stimulation

Interventions

Trancutaneous Auriculotemporal Nerve Stimulation

Trancutaneous Auriculotemporal Nerve Stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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);
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Mauro Barone

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad del Gran Rosario

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

25/20

Identifier Type: -

Identifier Source: org_study_id