Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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