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

Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment

Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Device: Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation; Device: Fake Stimulus

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 311100
      • Electrical stimulator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Transcetaneous Electrical Stimulation	Device: 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.
Placebo Comparator: Group B; Fake Stimulus Group	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce the intensity of migraine	After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).	Baseline and 2 hours post-treatment
the pre-selected accompanying symptoms	Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.	Baseline and 2 hours post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief	Pain relief measured by Visual Analogue Scale (VAS)：Number of participants transitioning from moderate to mild pain at 2 hours post-treatment.	Baseline and 2 hours post-treatment
returned to normal function	Number of participants who resumed normal daily activities (e.g., ability to ambulate freely or return to work/school) by 2 hours post-treatment.	Baseline and 2 hours post-treatment
Use of acute treatment drugs	Use of acute treatment drugs within 24 hours of treatment	Baseline and 24 hours post-treatment
recurrence of migraine	No recurrence of migraine attack occurred within 2-24 hours after treatment	Baseline and 2-24 hours post-treatment
recurrence of migraine2	No recurrence of migraine attack occurred within 2-48 hours after treatment	Baseline and 2-48 hours post-treatment
pain-free status	Participants achieved pain-free status (VAS score 0) at 15,30,45,60, and 90 minutes post-treatment, having progressed from moderate to severe pain.	Baseline and 15,30,45,60, and 90 minutes post-treatment
symptoms free	Participants' accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) did not reappear at 15,30,45,60, and 90 minutes after treatment	Baseline and 15,30,45,60, and 90 minutes post-treatment

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; Hangzhou Hospital of Traditional Chinese Medicine; The first people Hospital of Linhai; Huzhou Central Hospital

Publications and helpful links

General Publications

• Xavier Moisset,Bruno Pereira,Daniel Ciampi de Andrade, et al. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. The journal of headache and pain. 2020;21 (1):0-0. doi:10.1186/s10194-020-01204-4
• MW Weatherall,Dipankar Nandi. TM2-5 Percutaneous electrical nerve stimulation (PENS) therapy for refractory primary headache disorders: a pilot study. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY. 2019;90 (3):e14.1-e14. doi:10.1136/jnnp-2019-abn.43
• Ashina M, Katsarava Z, Do TP, Buse DC, Pozo-Rosich P, Özge A, Krymchantowski AV, Lebedeva ER, Ravishankar K, Yu S, Sacco S, Ashina S, Younis S, Steiner TJ, Lipton RB. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495. doi: 10.1016/S0140-6736(20)32160-7. Epub 2021 Mar 25. PMID: 33773613.
• Yusuf Tufail,Anna Yoshihiro,Sandipan Pati, et al. Ultrasonic neuromodulation by brain stimulation with transcranial ultrasound. Nature protocols. 2011;6 (9):1453-1470. doi:10.1038/nprot.2011.371
• Ziyan Tang,Quantao Ma,Qi Li, et al. Advances in applications of head mounted devices (HMDs): Physical techniques for drug delivery and neuromodulation. Journal of controlled release : official journal of the Controlled Release Society. 2023;354 (0):810-820. doi:10.1016/j.jconrel.2023.01.061

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: migraine; Transcetaneous Electrical Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2025-1038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is necessary to explore how personal information is protected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No