Clinical trial NCT06623188: Treatment of Episodic Migraine with AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
Official title: Treatment of Episodic Migraine with AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine Disorders
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).
timeFrame: 4 months
Secondary outcomes:
measure: Days without headache or migraine
timeFrame: 6 months
measure: Migraine attacks duration
timeFrame: 6 months
measure: Rate of responders, i.e., patients with a 50% reduction in the number of migraine days after treatment compared with the initial assessment
timeFrame: 6 months
measure: Quality of life of patients measured by SF-36 questionnaire
timeFrame: 6 months
measure: Functional disability due to headache or migraine as measured by MIDAS and HIT-6 questionnaires
timeFrame: 6 months
measure: Use of rescue medication
timeFrame: 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: BENNANI
Study officials:
References: