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Shock away migraines? new device trial shows promise

NCT ID NCT07451158

Symptom relief Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small device that sends gentle electrical pulses to nerves far from the head (called Ultra-Distal TENS) to see if it can reduce migraine pain and related symptoms like nausea and sensitivity to light or sound. About 206 adults with frequent migraines will use the device during an attack. The goal is to find a drug-free way to ease migraine symptoms quickly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • Electrical stimulator

    Hangzhou, Zhejiang, 311100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.