Auricular neuromodulation for episodic migraine
Official title: Treatment of Episodic Migraine With AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
Run by Hôpital Européen Marseille · NCT06623188 · Data updated 2026-11-12
This study will try a small electrical stimulation of the ear (auricular neuromodulation) to see if it reduces migraine days in adults 18–60 with moderate-to-severe episodic migraine who have not responded to at least two preventive medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Hôpital Européen Marseille Academic / other |
| Locations | 3 sites (Marseille and 2 other locations) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | November 20, 2027 |
| Study ends | November 20, 2027 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT06623188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with episodic migraine (4–14 migraine days per month) who have tried and not responded to at least two preventive medications.
✕Probably not a fit
People with chronic migraine (15 or more migraine days per month), active ear pathology, recent botulinum toxin or anti‑CGRP injections, or prior noninvasive auricular stimulation are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults meeting criteria for episodic migraine (4–14 migraine days per month) and prior failure of at least two preventive drugs are enrolled. Participants are assigned to receive either active auricular neuromodulation or a sham procedure and outcomes are compared between groups. The trial focuses on reducing the frequency of migraine attacks using a non-pharmacologic device-based approach. Safety exclusions include auricle pathology, recent botulinum toxin or anti‑CGRP injections, and prior noninvasive auricular stimulation.
Why it matters
Potential benefit: If successful, this could provide a non-drug preventive option that lowers monthly migraine days for patients who cannot tolerate or did not benefit from standard medications.
How similar studies have gone: Previous small trials of auricular or transcutaneous vagus nerve stimulation have shown mixed but sometimes promising results for migraine, so the approach has some preliminary evidence but is not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years ≥ Aged ≤ 60 years * Moderate to severe Migraine for at least one year * Migraines appeared before the age of 50 and diagnosed according to IHS (international headache society) criteria. * Therapeutic failure of at least 2 migraine preventive medications * Frequency of migraine days ≥ 4 per month and \< 15 per month Exclusion Criteria: * Pathology of the auricle (e.g. epithelioma) * Patient treated with botulinum toxin for migraine ≤ 2 months * Patient treated with anti-cgrp for migraine, with last injection less than 3 months ago * Patient treated with non-invasive auricular stimulation ( TENS)
Where it's running
-
Bennani
Marseille, France Recruiting -
Hôpital Européen Marseille
Marseille, France Recruiting -
Hôpital Européen Marseille
Marseille, France Recruiting
Study contacts
- Study coordinator: Myriam BENNANI
- Email: m.bennani@hopital-europeen.fr
- Phone: 0413428351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.