Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:57 AM
Study NCT ID:
NCT07451158
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce the intensity of migraine', 'timeFrame': 'Baseline and 2 hours post-treatment', 'description': 'After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).'}, {'measure': 'the pre-selected accompanying symptoms', 'timeFrame': 'Baseline and 2 hours post-treatment', 'description': 'Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.'}], 'secondaryOutcomes': [{'measure': 'pain relief', 'timeFrame': 'Baseline and 2 hours post-treatment', 'description': 'Pain relief measured by Visual Analogue Scale (VAS)：Number of participants transitioning from moderate to mild pain at 2 hours post-treatment.'}, {'measure': 'returned to normal function', 'timeFrame': 'Baseline and 2 hours post-treatment', 'description': 'Number of participants who resumed normal daily activities (e.g., ability to ambulate freely or return to work/school) by 2 hours post-treatment.'}, {'measure': 'Use of acute treatment drugs', 'timeFrame': 'Baseline and 24 hours post-treatment', 'description': 'Use of acute treatment drugs within 24 hours of treatment'}, {'measure': 'recurrence of migraine', 'timeFrame': 'Baseline and 2-24 hours post-treatment', 'description': 'No recurrence of migraine attack occurred within 2-24 hours after treatment'}, {'measure': 'recurrence of migraine2', 'timeFrame': 'Baseline and 2-48 hours post-treatment', 'description': 'No recurrence of migraine attack occurred within 2-48 hours after treatment'}, {'measure': 'pain-free status', 'timeFrame': 'Baseline and 15,30,45,60, and 90 minutes post-treatment', 'description': 'Participants achieved pain-free status (VAS score 0) at 15,30,45,60, and 90 minutes post-treatment, having progressed from moderate to severe pain.'}, {'measure': 'symptoms free', 'timeFrame': 'Baseline and 15,30,45,60, and 90 minutes post-treatment', 'description': "Participants' accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) did not reappear at 15,30,45,60, and 90 minutes after treatment"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine', 'Transcetaneous Electrical Stimulation'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Xavier Moisset,Bruno Pereira,Daniel Ciampi de Andrade, et al. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. The journal of headache and pain. 2020;21 (1):0-0. doi:10.1186/s10194-020-01204-4'}, {'type': 'RESULT', 'citation': 'MW Weatherall,Dipankar Nandi. TM2-5 Percutaneous electrical nerve stimulation (PENS) therapy for refractory primary headache disorders: a pilot study. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY. 2019;90 (3):e14.1-e14. doi:10.1136/jnnp-2019-abn.43'}, {'type': 'RESULT', 'citation': 'Ashina M, Katsarava Z, Do TP, Buse DC, Pozo-Rosich P, Özge A, Krymchantowski AV, Lebedeva ER, Ravishankar K, Yu S, Sacco S, Ashina S, Younis S, Steiner TJ, Lipton RB. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495. doi: 10.1016/S0140-6736(20)32160-7. Epub 2021 Mar 25. PMID: 33773613.'}, {'type': 'RESULT', 'citation': 'Yusuf Tufail,Anna Yoshihiro,Sandipan Pati, et al. Ultrasonic neuromodulation by brain stimulation with transcranial ultrasound. Nature protocols. 2011;6 (9):1453-1470. doi:10.1038/nprot.2011.371'}, {'type': 'RESULT', 'citation': 'Ziyan Tang,Quantao Ma,Qi Li, et al. Advances in applications of head mounted devices (HMDs): Physical techniques for drug delivery and neuromodulation. Journal of controlled release : official journal of the Controlled Release Society. 2023;354 (0):810-820. doi:10.1016/j.jconrel.2023.01.061'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged between 18 and 75;\n* According to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-III), the diagnosis is episodic migraine with or without aura or probable migraine with or without aura;\n* The duration of the illness is at least 12 months;\n* The age of onset of the first migraine is less than 50 years old;\n* During the screening period of 4 weeks, there were 2-8 episodes of headache, with moderate or severe pain intensity;\n* Before screening, the subjects should provide their previous medical records as much as possible;\n* Participants can distinguish migraines from other conditions, including tension-type headaches and cluster headaches\n* Understand and adhere to the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;\n\nExclusion Criteria:\n\n* Pregnant and lactating women;\n* Suffering from arrhythmia or other heart diseases (such as ischemic heart disease, coronary artery spasm, myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, angina pectoris);\n* Have undergone surgery within the past 6 months;\n* Recent stroke or transient ischemic attack;\n* Equipped with a pacemaker;\n* History of previous seizures;\n* Metal implants in the head;\n* Patients with clinical evidence of brain damage;\n* Chronic pain associated with other diseases;\n* Use antipsychotic drugs;\n* Those who are intolerant to neuroregulators;\n* Employees of the research center or their immediate family members.\n* There is a condition or anomaly that the investigator believes may affect patient safety or data quality'}, 'identificationModule': {'nctId': 'NCT07451158', 'briefTitle': 'Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment', 'orgStudyIdInfo': {'id': '2025-1038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Transcetaneous Electrical Stimulation', 'interventionNames': ['Device: Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Fake Stimulus Group', 'interventionNames': ['Device: Fake Stimulus']}], 'interventions': [{'name': 'Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation', 'type': 'DEVICE', 'description': 'When subjects report experiencing or impending headache episodes, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) therapy in the treatment area. Prior to activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Subsequently, activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. A safety follow-up (telephone consultation or online questionnaire) should be completed one week after the treatment session.', 'armGroupLabels': ['Group A']}, {'name': 'Fake Stimulus', 'type': 'DEVICE', 'description': 'When subjects experience or anticipate headache onset, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) in a non-treatment area. Before activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Then activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. Complete a safety follow-up one week after the same-day treatment (via telephone consultation or online questionnaire).', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '311100', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Electrical stimulator', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is necessary to explore how personal information is protected.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huzhou Central Hospital', 'class': 'OTHER'}, {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, {'name': 'Hangzhou Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'The first people Hospital of Linhai', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}