Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine

March 3, 2026 updated by: Semiha Yenişehir, Ordu University

The Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine: A Randomized Sham-Controlled, Double-Blind Study

This randomized, sham-controlled, and double-blind clinical study aims to investigate the effects of transcutaneous auricular trigeminal nerve stimulation (taTNS) on intensity of headache, sleep quality, level of disability, and Heart rate variability (HRV) in patients with migraine.

The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders, (4) having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months. The exclusion criteria were: (1) being pregnant or breastfeeding; (2) regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month; (3) pacemaker implantation; (4) a history of addiction, syncope or abnormal ECG findings; (5) a history of intracranial haemorrhage or significant head trauma; (6) a diagnosis of epilepsy, severe anxiety or depression; (7) other types of headaches, including paresthesia or medication-overuse headaches; and (8) cognitive, visual, or auditory problems that would prevent participation in the study.

The TaTNS was applied to the intervention and control (sham) groups by a physiotherapist (AP). The treatment session lasted 20 minutes and will apply three days a week for 12 weeks.

The physical (age, gender, height, body weight), sociodemographic (marital status, education level), and clinical characteristics (chronic diseases, medications used, age of migraine onset, migraine frequency in the last month, migraine treatment history) of participants will be recorded.

Primary outcome measurement: Migraine headache intensity (VAS), disability level (Migraine Disability Assessment Scale [MIDAS]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), Secondary outcome measurement: Heart rate variability (HRV) (Polar H7 device) will be assessed.

All calculations will be performed using 5-minute Polar H7 recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants with migraine headache will be randomly assigned to the two groups (TaTNS and sham TaTNS) in equal numbers using software (https://www.randomizer.org/).

The TaTNS will be applied to the intervention and control (sham) groups by a physiotherapist (AP). The intervention will be applied three days a week for 12 weeks, with 20 minutes session duration.

A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) will be used for stimulation. In both groups, clip-on bipolar electrodes were placed on the upper-anterior part of the auricle. The bilateral auricular stimulation protocols as follows: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA.

Sham TaTNS The sham-TaTNS application was performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation was applied at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve.

The sham group received a frequency of 1 Hz and a current intensity of up to 1 mA.

To assess the success rate of the blinding technique, at the end of the treatment period, each participant was asked to guess which treatment group they belonged to. Additionally, level of confidence in their guesses regarding the groups they belonged to was assessed using the Visual Analog Scale (VAS) (0-10 cm).

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being aged 18-45 years,
  • being literate in Turkish
  • having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders,
  • having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months.

Exclusion Criteria:

  • being pregnant or breastfeeding;
  • regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month;
  • pacemaker implantation;
  • a history of addiction, syncope or abnormal ECG findings;
  • a history of intracranial haemorrhage or significant head trauma;
  • a diagnosis of epilepsy, severe anxiety or depression;
  • other types of headaches, including paresthesia or medication-overuse headaches;
  • cognitive, visual, or auditory problems that would prevent participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TaTNS group
Transcutaneus auricular trigeminal nerve stimulation A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) is used for stimulation. In both groups, clip-on bipolar electrodes place on the upper-anterior part of the auricle.The bilateral auricular stimulation protocols: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA
Device: Transcutaneous Auricular Trigeminal Nerve Stimulation
Transcutaneous Auricular Trigeminal Nerve Stimulation TaTNS stimulation is applied using a dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) with clip-on bipolar electrodes placed on the upper anterior part of the auricle. This region is innervated by the trigeminal nerve via the auriculotemporal nerve. Electrode gel is also used to facilitate electrical conductivity. Bilateral ear stimulation protocols are as follows: Two-phase rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity maximum 16 mA.
Sham Comparator: Sham TaTNS

Sham control group:

The sham-TaTNS application will performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation will apply at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve.

The sham group will receive a frequency of 1 Hz and a current intensity of up to 1 mA
Other: Sham (No Treatment)

The sham-TaTNS application will performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation will applied at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve.

The sham group will receive a frequency of 1 Hz and a current intensity of up to 1 mA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Headache
Time Frame: baseline and after intervention day 1
Visual Analog Scale (0-10 cm)
baseline and after intervention day 1
Migraine Disability Assessment Scale [MIDAS])
Time Frame: baseline and after intervention day 1
Migraine Disability Assessment Scale [MIDAS]): The MIDAS questionnaire has been shown to be reliable and valid for determining the degree of disability caused by migraine. The Turkish version of the MIDAS shown to be reliable and valid by Ertaş et al., contains 5 questions assessing disability status over the past 3 months. Patients score the number of days lost due to headache in three areas: school or paid work; housework; family, social, or leisure activities. The number of additional days with significant activity limitations (defined as at least a 50% decrease in productivity) in the paid work and household chores domains is also assessed. The MIDAS score is the sum of the scores for these five questions. Two additional questions (A and B) are not scored.
baseline and after intervention day 1
Pittsburgh Sleep Quality Index
Time Frame: baseline and after intervention day 1
Pittsburgh Sleep Quality Index The validity and reliability of the Turkish version of the PSQI, developed by Buysse et al. (1989), have been demonstrated. The scale consists of a total of 24 items, 19 of which are self-reported. Five questions are answered by a spouse or roommate and are used only for clinical information, not for scoring. Item 19, which is self-reported, is also not used in room scoring. A total score >5 indicates poor sleep quality.
baseline and after intervention day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: baseline and after intervention day 1
HRV will be measured using the Polar H7 device (Copyright 2016 Polar Electro Oy, FI-90440 Kempele, Finland). The data transferred to the Polar Flow app was analyzed using the Kubios BHR Standard (version 3.5.0) (www.kubios.com). The HRV measurement will set to five minutes (short term) due to the difficulty of taking measurements over a 24-hour period (long term). It is also recommended that HRV measurements are taken at intervals of at least five minutes to eliminate the margin of error in repeated measurements. All measurements will taken in a quiet room at a temperature of 20-22 °C (68-77 °F) with the patient seated. Changes in RMSSD (root mean square of beat-to-beat successive differences), low frequency (LF) power, and high frequency (HF) parameters were recorded from the data analyzed in the HRV measurement.
baseline and after intervention day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ordu University

Investigators

  • Principal Investigator: SEMİHA YENİŞEHİR, Ordu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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