Migraine DisordersMENAURICNCT06623188
Treatment of Episodic Migraine With AURICular Neuromodulation
A study testing Auricular neuromodulation in people with Migraine Disorders, run by Hôpital Européen Marseille at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Auricular neuromodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 3 sitesFrance
- Study dates
- 20 May 2025to 20 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
BENNANI
Marseille, 13003
Myriam BENNANI, 0413428351, m.bennani@hopital-europeen.fr
Emmanuel SAGUI, Dr
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Myriam BENNANI, m.bennani@hopital-europeen.fr
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Myriam BENNANI, 0413428351, m.bennani@hopital-europeen.fr
Frédérique RETORNAZ
About this study
Official title: Treatment of Episodic Migraine With AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
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.
- Conditions
- Migraine Disorders
- Being tested
- Auricular neuromodulation, Sham auricular neuromodulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular neuromodulationOther
3 neuromodulation sessions over 12 weeks
Sham auricular neuromodulationOther
3 neuromodulation sessions over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Auricular neuromodulation | Experimental | Not described Receives: Other: Auricular neuromodulation |
| Sham auricular neuromodulation | Sham comparator | Not described Receives: Other: Sham auricular neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).
Measured: 4 months
Secondary outcomes (6)
Days without headache or migraine
Measured: 6 months
Migraine attacks duration
Measured: 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
Measured: 6 months
Quality of life of patients measured by Study Short Form 36 (SF-36) questionnaire
Measured: 6 months
Functional disability due to headache or migraine as measured by MIgraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) questionnaires
Measured: 6 months
Use of rescue medication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start20 May 2025
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623188
- Sponsor's protocol ID
- 24-05
- Acronym
- MENAURIC
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41088062
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Episodic Migraine With AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06623188
- Acronym / sponsor ID
- MENAURIC / 24-05
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular neuromodulation | Experimental | Other: Auricular neuromodulation |
| Sham auricular neuromodulation | Sham comparator | Other: Sham auricular neuromodulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular neuromodulation3 neuromodulation sessions over 12 weeks | Other | Auricular neuromodulation |
| Sham auricular neuromodulation3 neuromodulation sessions over 12 weeks | Other | Sham auricular neuromodulation |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 41088062Sagui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular neuromodulation in people with Migraine Disorders, run by Hôpital Européen Marseille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myriam BENNANI (0413428351, m.bennani@hopital-europeen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.