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 neuroregulators;
• Employees of the research center or their immediate family members.
• There is a condition or anomaly that the investigator believes may affect patient safety or data quality