Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:59 PM
Study NCT ID:
NCT07457268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of Headache', 'timeFrame': 'baseline and after intervention day 1', 'description': 'Visual Analog Scale (0-10 cm)'}, {'measure': 'Migraine Disability Assessment Scale [MIDAS])', 'timeFrame': 'baseline and after intervention day 1', 'description': '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.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline and after intervention day 1', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability', 'timeFrame': 'baseline and after intervention day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigeminal stimulation', 'headache', 'heart rate variability'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '25807067', 'type': 'BACKGROUND', 'citation': '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': '15330825', 'type': 'BACKGROUND', 'citation': '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': '11098098', 'type': 'BACKGROUND', 'citation': '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': '26755617', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nPrimary 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.\n\nAll 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.', 'detailedDescription': "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/).\n\nThe 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.\n\nA 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.\n\nSham 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.\n\nThe sham group received a frequency of 1 Hz and a current intensity of up to 1 mA.\n\nTo 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being aged 18-45 years,\n* being literate in Turkish\n* having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders,\n* having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months.\n\nExclusion Criteria:\n\n* being pregnant or breastfeeding;\n* regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month;\n* pacemaker implantation;\n* a history of addiction, syncope or abnormal ECG findings;\n* a history of intracranial haemorrhage or significant head trauma;\n* a diagnosis of epilepsy, severe anxiety or depression;\n* other types of headaches, including paresthesia or medication-overuse headaches;\n* cognitive, visual, or auditory problems that would prevent participation in the study.'}, 'identificationModule': {'nctId': 'NCT07457268', 'briefTitle': 'Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'The Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine: A Randomized Sham-Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': '2025/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TaTNS group', 'description': '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', 'interventionNames': ['Device: Transcutaneous Auricular Trigeminal Nerve Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TaTNS', 'description': "Sham control group:\n\nThe 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.\n\nThe sham group will receive a frequency of 1 Hz and a current intensity of up to 1 mA", 'interventionNames': ['Other: Sham (No Treatment)']}], 'interventions': [{'name': 'Transcutaneous Auricular Trigeminal Nerve Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['TaTNS group']}, {'name': 'Sham (No Treatment)', 'type': 'OTHER', 'description': "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.\n\nThe sham group will receive a frequency of 1 Hz and a current intensity of up to 1 mA", 'armGroupLabels': ['Sham TaTNS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SEMİHA YENİŞEHİR, PT,PhD', 'role': 'CONTACT', 'email': 'ysehir.semiha8@gmail.com', 'phone': '+904522265248'}], 'overallOfficials': [{'name': 'SEMİHA YENİŞEHİR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Semiha Yenişehir', 'investigatorAffiliation': 'Ordu University'}}}}