Acute Treatment of Migraine Using the CEFALY Device

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.

Official Title
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Open-trial on the Acute Treatment of Migraine Using the CEFALY Device

Conditions
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Migraine

Intervention / Treatment
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* Device: CEFALY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction) The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side. Exclusion Criteria: Pregnant women Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head in the prior 4 months Patients having received supraorbital nerve blocks in the prior 4 months Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache Patients with only temporal or occipital headaches Patients taking opioid medications Patients having taken abortive migraine medication in the prior 3 hours Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started). Implanted metal or electrical devices in the head Cardiac pacemaker or implanted or wearable defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>60 minutes of CEFALY stimulation as acute treatment of an on-going attack | Device: CEFALY<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain intensity at 1 hour (VAS score) | Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain intensity at 2 hours (VAS score) | Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 | 2 hours | 
| Patients with no need of medication at 2 hours | Percentage of patients not having required rescue medication after 2 hours | 2 hours | 
| Patients with no need of medication at 24 hours | Percentage of patients not having required rescue medication after 2 hours | 24 hours |