Menu
Recruiting NCT06623188

Treatment of Episodic Migraine With AURICular Neuromodulation

No phase Interventional Migraine Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular neuromodulation, Sham auricular neuromodulation.
Who it may be relevant to
Registry conditions: Migraine Disorders. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

France · 3 centers
  • BENNANI — Marseille
  • Hôpital Européen Marseille — Marseille
  • Hôpital Européen Marseille — Marseille

Publications

  • 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

Identifiers

NCT: NCT06623188 · 24-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗