An interventional study of Auricular neuromodulation and Sham auricular neuromodulation in Migraine Disorders, sponsored by Hôpital Européen Marseille. Recruiting at 3 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Hôpital Européen Marseille · Not applicable, Interventional, and Other
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 106 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Hôpital Européen Marseille is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Auricular neuromodulation
Other: Sham auricular neuromodulation
3 neuromodulation sessions over 12 weeks
3 neuromodulation sessions over 12 weeks
Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).
Time frame: 4 months
Days without headache or migraine
Time frame: 6 months
Migraine attacks duration
Time frame: 6 months
Rate of responders, i.e., patients with a 50% reduction in the number of migraine days after treatment compared with the initial assessment
Time frame: 6 months
Quality of life of patients measured by Study Short Form 36 (SF-36) questionnaire
Time frame: 6 months
Functional disability due to headache or migraine as measured by MIgraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) questionnaires
Time frame: 6 months
Use of rescue medication
Time frame: 6 months
Plan to share: No
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Hôpital Européen Marseille