NCT07451158

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Nov 2025Oct 2026

Study Start

First participant enrolled

November 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

March 5, 2026

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 17, 2025

Last Update Submit

February 27, 2026

Conditions

Migraine

Keywords

migraineTranscetaneous Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • pain relief

    Baseline and 2 hours post-treatment

  • returned to normal function

    Baseline and 2 hours post-treatment

  • Use of acute treatment drugs

    Baseline and 24 hours post-treatment

  • recurrence of migraine

    Baseline and 2-24 hours post-treatment

  • recurrence of migraine2

    Baseline and 2-48 hours post-treatment

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Transcetaneous Electrical Stimulation

Device: Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation

Group B

PLACEBO COMPARATOR

Fake Stimulus Group

Device: Fake Stimulus

Interventions

Trail of Ultral-distal Transcutaneous Electrical Nerve StimulationDEVICE

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.

Group A
Fake StimulusDEVICE

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).

Group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Electrical stimulator

Hangzhou, Zhejiang, 311100, China

Location

Related Publications (5)

  • 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

    RESULT

  • 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

    RESULT

  • 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.

    RESULT

  • 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

    RESULT

  • 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

    RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

March 5, 2026

Study Start

November 15, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

March 5, 2026

Record last verified: 2025-11

Locations

CN(1)