Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine

NCT07457268 | Not Yet Recruiting

• 1 other identifier: 2025/5
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine

Keywords

Trigeminal stimulation; headache; heart rate variability

Outcome Measures

Primary Outcomes (3)

• Intensity of Headache

  Visual Analog Scale (0-10 cm)

  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.

  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.

  baseline and after intervention day 1

Secondary Outcomes (1)

• Heart Rate Variability

  baseline and after intervention day 1

Study Arms (2)

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

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, 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)

Interventions

Transcutaneous Auricular Trigeminal Nerve Stimulation DEVICE

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.

TaTNS group

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, 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

Sham TaTNS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Related Publications (4)

• 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.

  PMID: 25807067 BACKGROUND

• 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.

  PMID: 15330825 BACKGROUND

• 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.

  PMID: 11098098 BACKGROUND

• 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.

  PMID: 26755617 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SEMİHA YENİŞEHİR

  Ordu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEMİHA YENİŞEHİR, PT,PhD

CONTACT

+904522265248; ysehir.semiha8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share