Treatment of Episodic Migraine With AURICular Neuromodulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHôpital Européen Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auricular neuromodulation

    Other intervention

    3 neuromodulation sessions over 12 weeks

  • Sham auricular neuromodulation

    Other intervention

    3 neuromodulation sessions over 12 weeks

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Auricular neuromodulationExperimental treatment 1 intervention
Group B: Sham auricular neuromodulationSham comparator 1 intervention

Trial outcomes

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).

Time frame
4 months

Secondary outcomes

1

Days without headache or migraine

Time frame
6 months
2

Migraine attacks duration

Time frame
6 months
3

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
4

Quality of life of patients measured by Study Short Form 36 (SF-36) questionnaire

Time frame
6 months

Other outcomes

Sponsors and contacts

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