Home-based Transcutaneous Auricular Vagus Nerve Stimulation for the Prevention of Migraine:a Multicenter Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: 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, intensity at maximum tolerable level (1.5‐5mA), left ear acupoint stimulation, 3 times per week, 1 hour each session, total 12 sessions (4‐week treatment period + 8‐week follow‐up);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, intensity at maximum tolerable level (1.5‐5mA), left ear acupoint stimulation, 3 times per week, 1 hour each session, total 12 sessions (4‐week treatment period + 8‐week follow‐up); CONDITION: Migraine PRIMARY OUTCOME: Migraine day; SECONDARY OUTCOME: 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; 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
Epistemonikos ID: 590c545c47be37b29a80b3aab7883389fb299c93
First added on: Jul 21, 2026