Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06623188

Treatment of Episodic Migraine With AURICular Neuromodulation

Led by Hôpital Européen Marseille · Updated on 2025-07-01

106

Participants Needed

3

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Migraine is a ubiquitous pathology affecting approximately 1 billion individuals and being the leading cause of morbidity worldwide before the age of 50. Migraine treatment consists of two main approaches: acute treatment to relieve headache symptoms and preventive treatment to reduce the frequency of migraine attacks by at least 50%. Preventive treatment involves medications such as beta-blockers, antiepileptics, calcium channel blockers, and a new therapeutic class called calcitonin gene-related peptide (CGRP) inhibitors. While traditional treatments have modest efficacy and limited tolerability, CGRP inhibitors have shown better tolerability and superior efficacy. However, their prescription in France is restricted to neurologists and specialized pain evaluation and treatment units. Additionally, the long-term effects of CGRP inhibition on blood pressure control and vascular homeostasis are not fully understood. In addition to pharmacological preventive treatment, non-pharmacological approaches have emerged, such as auricular neurostimulation. This can be achieved through electrical stimulation of the cymba conchae, considered a non-invasive alternative to invasive vagal stimulation, and has shown benefits in reducing the number of migraine days compared to a placebo. Another approach involves stimulation of specific areas of the entire auricle using techniques borrowed from auriculotherapy (auricular acupuncture). The objective of the study is to demonstrate that auricular neuromodulation, performed with a laser device, targeted and personalized on selected areas of the auricle, has a beneficial effect on the number of moderate to severe migraine days per month.

CONDITIONS

Official Title

Treatment of Episodic Migraine With AURICular Neuromodulation

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Moderate to severe migraine for at least one year
  • Migraine started before age 50 and diagnosed by International Headache Society criteria
  • Failed treatment with at least two preventive migraine medications
  • Frequency of migraine days between 4 and less than 15 per month
Not Eligible

You will not qualify if you...

  • Ear disorders such as epithelioma
  • Treatment with botulinum toxin for migraine within the last 2 months
  • Treatment with anti-CGRP for migraine with last injection less than 3 months ago
  • Treatment with non-invasive auricular stimulation (TENS)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

BENNANI

Marseille, France, 13003

Actively Recruiting

2

Hôpital Européen Marseille

Marseille, France, 13003

Actively Recruiting

3

Hôpital Européen Marseille

Marseille, France, 13003

Actively Recruiting

Loading map...

Research Team

M

Myriam BENNANI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here