Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment

Inclusion Criteria: * Male or female, aged between 18 and 75; * 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; * The duration of the illness is at least 12 months; * The age of onset of the first migraine is less than 50 years old; * During the screening period of 4 weeks, there were 2-8 episodes of headache, with moderate or severe pain intensity; * Before screening, the subjects should provide their previous medical records as much as possible; * Participants can distinguish migraines from other conditions, including tension-type headaches and cluster headaches * Understand and adhere to the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; Exclusion Criteria: * Pregnant and lactating women; * 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); * Have undergone surgery within the past 6 months; * Recent stroke or transient ischemic attack; * Equipped with a pacemaker; * History of previous seizures; * Metal implants in the head; * Patients with clinical evidence of brain damage; * Chronic pain associated with other diseases; * Use antipsychotic drugs; * Those who are intolerant to neuroregulato…