Treatment of Episodic Migraine With AURICular Neuromodulation (MENAURIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Other: Auricular neuromodulation; Other: Sham auricular neuromodulation

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myriam BENNANI; Phone Number: 0413428351; Email: m.bennani@hopital-europeen.fr

Study Locations

• France
  • Marseille, France, 13003
    • Recruiting
    • Hopital Europeen Marseille
    • Principal Investigator: Frédérique RETORNAZ
    • Contact: Myriam BENNANI; Phone Number: 0413428351; Email: m.bennani@hopital-europeen.fr
  • Marseille, France, 13003
    • Recruiting
    • BENNANI
    • Contact: Myriam BENNANI; Phone Number: 0413428351; Email: m.bennani@hopital-europeen.fr
    • Principal Investigator: Emmanuel SAGUI, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular neuromodulation	Other: Auricular neuromodulation; 3 neuromodulation sessions over 12 weeks
Sham Comparator: Sham auricular neuromodulation	Other: Sham auricular neuromodulation; 3 neuromodulation sessions over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Days without headache or migraine	6 months
Migraine attacks duration	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	6 months
Use of rescue medication	6 months
Quality of life of patients measured by Study Short Form 36 (SF-36) questionnaire	6 months
Functional disability due to headache or migraine as measured by MIgraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) questionnaires	6 months

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 24-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No