Treatment of Episodic Migraine With AURICular Neuromodulation

NCT06623188 | Recruiting

• 1 other identifier: 24-05
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief Summary

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

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (2)

Auricular neuromodulation

EXPERIMENTAL

Other: Auricular neuromodulation

Sham auricular neuromodulation

SHAM COMPARATOR

Other: Sham auricular neuromodulation

Interventions

Auricular neuromodulation OTHER

3 neuromodulation sessions over 12 weeks

Auricular neuromodulation

Sham auricular neuromodulation OTHER

3 neuromodulation sessions over 12 weeks

Sham auricular neuromodulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (3)

BENNANI

Marseille, 13003, France

RECRUITING

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

Related Publications (1)

• Sagui E, Kereun E, Guillemet G, Faralli H, Perananda G, Bennani M, Berthelier C. Auricular neuromodulation by low level laser therapy versus placebo laser therapy in prophylactic treatment of episodic migraine: a randomized controlled study protocol. BMC Complement Med Ther. 2025 Oct 14;25(1):371. doi: 10.1186/s12906-025-05068-6.

  PMID: 41088062 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Myriam BENNANI

CONTACT

0413428351; m.bennani@hopital-europeen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)