MigraineNCT07457268

Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine

A study testing Transcutaneous Auricular Trigeminal Nerve Stimulation in people with Migraine, run by Ordu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized, sham-controlled, and assessor and participants-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. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Migraine
What is being tested?: Transcutaneous Auricular Trigeminal Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Jan 2026to 30 Jun 2026
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

being aged 18-45 years,
being literate in Turkish
having been diagnosed with episodic 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ordu University
Ordu, Ordu, 52200

Other trials in Turkey (Türkiye)

About this study

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

The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic 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 H10 device) will be assessed.

All calculations will be performed using 5-minute Polar H10 device recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.

Read the 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.

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. 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 0 Hz and a current intensity of 0 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).

Conditions: Migraine
Being tested: Transcutaneous Auricular Trigeminal Nerve Stimulation, Sham (No Treatment)
Keywords: Trigeminal stimulation, headache, heart rate variability
Medical subject headings: Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Auricular Trigeminal Nerve StimulationDevice
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 (No Treatment)Other
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 at 0mA intensity. 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.

Study groups in NCT07457268
Study group	Role	What they receive
TaTNS group	Experimental	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 Receives: Device: Transcutaneous Auricular Trigeminal Nerve Stimulation
Sham TaTNS	Sham comparator	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. 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 current intensity of up to 0 mA. Receives: Other: Sham (No Treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensity of Headache
Visual Analog Scale (0-10 cm)
Measured: baseline and after intervention day 1
Migraine Disability Assessment Scale [MIDAS])
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.
Measured: baseline and after intervention day 1
Pittsburgh Sleep Quality Index
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.
Measured: baseline and after intervention day 1

Secondary outcomes (1)

Heart Rate Variability
HRV will be measured using the Polar H10 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.
Measured: baseline and after intervention day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202630 Jun 2026

First posted9 Mar 2026
Study start30 Jan 2026
Primary completion2 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for MigraineStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07457268
Sponsor's protocol ID: 2025/5
Status last verified: Aug 2026
First submitted: 15 Jan 2026
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Baek HJ, Cho CH, Cho J, Woo JM. Reliability of ultra-short-term analysis as a surrogate of standard 5-min analysis of heart rate variability. Telemed J E Health. 2015 May;21(5):404-14. doi: 10.1089/tmj.2014.0104. Epub 2015 Mar 25.
PubMed 25807067
Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M; Turkish MIDAS group. Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2004 Sep;44(8):786-93. doi: 10.1111/j.1526-4610.2004.04146.x.
PubMed 15330825
Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000 Oct;88(1):41-52. doi: 10.1016/S0304-3959(00)00305-5.
PubMed 11098098
Schoenen JE. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2016 Jan 12;86(2):201-2. doi: 10.1212/01.wnl.0000479686.32453.cc. No abstract available.
PubMed 26755617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine: A Randomized Sham-Controlled, Double-Blind Study
ClinicalTrials.gov ID: NCT07457268
Acronym / sponsor ID: 2025/5
Conditions: Migraine
Keywords: Trigeminal stimulation, headache, heart rate variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Ordu UniversityUniversity, hospital or other
Study start: 30 Jan 2026 (actual)
Primary completion: 2 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 9 Mar 2026 (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.

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.

All calculations will be performed using 5-minute Polar H10 device recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TaTNS group	Experimental	Device: Transcutaneous Auricular Trigeminal Nerve StimulationTranscutaneus 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
Sham TaTNS	Sham comparator	Other: Sham (No Treatment)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. 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 current intensity of up to 0 mA.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

being aged 18-45 years,
being literate in Turkish
having been diagnosed with episodic 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.

Key exclusion criteria (8 listed)

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;

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
Transcutaneous Auricular Trigeminal Nerve StimulationTranscutaneous 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.	Device	TaTNS group
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 at 0mA intensity. 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.	Other	Sham TaTNS

Primary outcome

Intensity of Headache
Time frame: baseline and after intervention day 1
Visual Analog Scale (0-10 cm)
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.
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.

1 secondary outcome

Heart Rate Variability
Time frame: baseline and after intervention day 1

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 2 Sep 2026.
Background: PubMed 25807067Baek HJ, Cho CH, Cho J, Woo JM. Reliability of ultra-short-term analysis as a surrogate of standard 5-min analysis of heart rate variability. Telemed J E Health. 2015 May;21(5):404-14. doi: 10.1089/tmj.2014.0104. Epub 2015 Mar 25.
Background: PubMed 15330825Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M; Turkish MIDAS group. Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2004 Sep;44(8):786-93. doi: 10.1111/j.1526-4610.2004.04146.x.
Background: PubMed 11098098Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000 Oct;88(1):41-52. doi: 10.1016/S0304-3959(00)00305-5.
Background: PubMed 26755617Schoenen JE. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2016 Jan 12;86(2):201-2. doi: 10.1212/01.wnl.0000479686.32453.cc. No abstract available.
Individual participant dataSharing planned: No

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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.

SEMİHA YENİŞEHİR principal investigator

Ordu University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Trigeminal Nerve Stimulation in people with Migraine, run by Ordu University at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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 2 Sep 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

Intensity of Headache (time frame: baseline and after intervention day 1). 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?

On the ClinicalTrials.gov record for NCT07457268, which also lists 4 linked publications.

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 2 Sep 2026.