Recruiting

Testing nerve stimulation on the ear for childhood headaches

Plain-English translation of NCT06277063 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing a noninvasive vagus nerve stimulation (nVNS) device — a small tool that gently stimulates a nerve in your ear — to see if it can help relieve headache pain when you have a migraine, cluster headache, or tension headache. The treatment is designed for children and teenagers between ages 7 and 20. Researchers will measure how much your headache pain improves after using the device and will track your heart rhythm to understand how the treatment works.

Many young people suffer from frequent, painful headaches, and current treatments don't work well for everyone. This trial is exploring whether this medication offers a new, non-invasive way to quickly reduce pain during acute headache attacks without the need for pills or more invasive procedures.

Do you qualify?

You likely qualify if…

you are between 7 and 20 years old
you have been diagnosed with migraine, cluster headache, or tension-type headache according to current clinical guidelines
you have experienced headaches on 3 to 15 days per month
you are willing to keep your current headache medications at a stable dose throughout the trial and not start any new medications
you and your parent or guardian are willing to participate and sign the informed consent form

You likely don't qualify if…

you have a history of secondary headaches, brain tumors, aneurysms, severe head trauma, or seizures
you have had previous vagus nerve surgery or implanted electronic devices such as a pacemaker or hearing aid
you are currently using other nerve or muscle stimulation devices
you are taking high doses of opioids, pain relievers, or other medications more frequently than the study allows
you have significant heart problems, including congenital heart disease, severe high or low blood pressure, or abnormal heart rhythms

What participation looks like

When you experience a headache, you will contact the research team and come in within 20 minutes of your headache starting. You will wear the nerve stimulation device on your ear for 30 minutes while researchers monitor your heart rhythm with an ECG and measure your neck muscles with electromyography. Your headache pain will be assessed immediately after treatment, and again at 2 hours, 8–12 hours, 24 hours, and 36–48 hours later to see how much improvement occurs. The entire process takes about an hour per headache episode.

AI-generated summary from trial data · Jun 1, 2026 · Not medical advice

Testing nerve stimulation on the ear for childhood headaches

What is this trial?

Do you qualify?

What participation looks like

Trial locations