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Treatment of Episodic Migraine With AURICular Neuromodulation

Study acronym: MENAURIC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary and study completion dates: Oct 1, 2026 to Nov 20, 2027
    • Start date changed from estimate of Nov 1, 2024 to May 20, 2025
    • Study sites: 1 to 3
    • Secondary endpoints revised (6)
    • Study title shortened, about 5 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06623188
Lead Sponsor Hôpital Européen Marseille
Conditions
(from sponsor)
Migraine Disorders
Related terms Migraine Disorders
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov