Migraine
Conditions
Interventions
Transcutaneous Ear Acupoint Vagus Nerve Stimulation Group (A Group):Left ear acupoints Liver and Pancreas-Bile (vagus nerve branch distribution area), parameters: frequency 1Hz, pulse width 0.2ms, int
Transcutaneous Ear Acupoint Non-Vagus Nerve Stimulation Group (B Group):Left ear acupoints Occiput and Temporal (non-vagus nerve distribution area), parameters: frequency 1Hz, pulse width 0.2ms, inten
Sponsors
Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years; 2. Meet the diagnostic criteria for migraine without aura; 3. Have experienced at least 1 migraine attack per month in the past 3 months; 4. Have not used any oral, injectable, or intravenous prophylactic medications (ß-blockers, calcium channel blockers, antiepileptics, antidepressants, CGRP monoclonal antibodies, etc.) in the past month; 5. Have not received auricular point transcutaneous electrical stimulation, acupuncture, botulinum toxin, neuromodulation, or other non-pharmacological preventive interventions in the past month; 6. No medication-overuse headache in the past 3 months (NSAIDs > 15 days/month or caffeine-containing compound preparations > 10 days/month); 7. Be willing to receive auricular point transcutaneous electrical stimulation; 8. The subject himself/herself or his/her immediate family member has signed the informed consent form. Note: Only subjects who meet all the above 8 criteria may be included in the study.
Exclusion criteria
Exclusion criteria: 1. Headache is a symptom of other diseases, such as hypertension; 2. Have other subtypes of migraine (e.g., migraine with aura, ophthalmoplegic migraine, hemiplegic migraine, etc.), or headache symptoms more consistent with other primary headaches (e.g., tension-type headache) or secondary headaches (e.g., intracranial lesions, metabolic diseases, etc.); 3. Suffer from other diseases causing cognitive impairment and mental abnormalities, including dementia of various etiologies, affective disorders, and schizophrenia; 4. Unconsciousness and inability to cooperate with examinations and treatments; 5. Complicated with severe primary diseases such as cancer, heart, liver, kidney, hematopoietic system diseases, etc.; 6. Patients with implanted devices, including cardiac pacemakers, cochlear implants, and intracranial vascular stents; 7. Patients currently receiving other neurostimulation/modulation therapies; 8. Pregnant or lactating women, or women planning to conceive within the past six months; 9. Participated in other clinical studies within 1 month before enrollment; 10. Patients with infection, ulcer, or severe skin disease on the auricle. Note: Subjects meeting any of the above 10 criteria will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Migraine day;Responder rate;Average VAS scores for headaches;Moderate/severe headache day;Number of headache attacks;Frequency of acute analgesic administration;Migraine-Specific Quality of Life questionnaire;Emotion-related scale; | — |
Countries
China
Contacts
Public ContactLi Zhengjie
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed