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Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

NCT07451158•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

Locations (1)

Electrical stimulator

Hangzhou, Zhejiang, China

Key Dates

Start Date

November 15, 2025

Primary Completion Date

October 30, 2026

Completion Date

October 30, 2026

Last Updated

March 5, 2026

Enrollment

206

ESTIMATED participants

Conditions

Migraine

Interventions

Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation

DEVICE

Fake Stimulus

DEVICE

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

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Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.