Treatment of Episodic Migraine With AURICular Neuromodulation
Recruiting · NCT06623188 · Interventional (participants receive a specific treatment) · Lead sponsor: Hôpital Européen Marseille
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
3 locations listed.
- BENNANI - Marseille, France
- Hôpital Européen Marseille - Marseille, France
- Hôpital Européen Marseille - Marseille, France