Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-11-15
Last updated
2026-03-05
Condition(s) studied
Migraine
Investigational drug(s) / intervention(s)
Trail of Ultral-distal Transcutaneous Electrical Nerve StimulationFake Stimulus
Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation: 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.
Fake Stimulus: 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).
Study summary
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Reduce the intensity of migraine — Baseline and 2 hours post-treatment After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).
the pre-selected accompanying symptoms — Baseline and 2 hours post-treatment Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.
Trial sites (1)
Facility
City
Region
Status
Electrical stimulator
Hangzhou
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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