Treatment of Episodic Migraine With AURICular Neuromodulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2027-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Auricular neuromodulation

Group Type EXPERIMENTAL

Auricular neuromodulation

Intervention Type OTHER

3 neuromodulation sessions over 12 weeks

Sham auricular neuromodulation

Group Type SHAM_COMPARATOR

Sham auricular neuromodulation

Intervention Type OTHER

3 neuromodulation sessions over 12 weeks

Interventions

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Auricular neuromodulation

3 neuromodulation sessions over 12 weeks

Intervention Type OTHER

Sham auricular neuromodulation

3 neuromodulation sessions over 12 weeks

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No