Treatment of Episodic Migraine with AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study

Launched by HÔPITAL EUROPÉEN MARSEILLE · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who suffer from episodic migraines, which are painful headaches that can happen frequently. The researchers want to see if a non-invasive method called auricular neuromodulation, which involves using a laser on specific areas of the ear, can help reduce the number of migraine days experienced each month. This approach is being tested alongside traditional treatments, like medication, to see if it offers additional benefits for patients.

To participate in the trial, individuals must be between 18 and 60 years old, have experienced moderate to severe migraines for at least a year, and have tried at least two different preventive migraine medications without success. Participants should have four to fifteen migraine days each month. Those interested in joining the study can expect to receive targeted treatment using the laser device and will be monitored to see how it affects their migraine frequency. It’s important to note that people with certain ear conditions or those currently undergoing specific migraine treatments may not be eligible to participate.

Gender

ALL

Eligibility 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)