Treatment of Episodic Migraine With AURICular Neuromodulation

Официальное название

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

Обзор

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.

Вмешательства

• Другое Auricular neuromodulation
  3 neuromodulation sessions over 12 weeks
• Другое Sham auricular neuromodulation
  3 neuromodulation sessions over 12 weeks

Первичные конечные точки

• Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation). [Срок оценки: 4 months]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 3 центра

• BENNANI — Marseille
• Hôpital Européen Marseille — Marseille
• Hôpital Européen Marseille — Marseille

Публикации

• 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

Идентификаторы

NCT: NCT06623188 · 24-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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