Acute Treatment of Migraine With e-TNS

Study Overview
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Brief Summary
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The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.

Official Title
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Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device

Conditions
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Migraine

Intervention / Treatment
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* Device: CEFALY Active
* Device: CEFALY Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction) Having a migraine attack lasting at least 3 hours Migraine pain intensity stabilized for at least 1 hour Frontal, retro-, or peri- orbital headache. Exclusion Criteria: Pregnant women Patients having received Botox treatment 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 headache Patients using opioid medication 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 if they are unable to tolerate the first 5 minutes of neurostimulation). Implanted metal or electrical devices in the head Cardiac pacemaker or implanted or wearable defibrillator Patient having had a previous experience with Cefaly®

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active device<br>60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device | Device: CEFALY Active<br>* Active external trigeminal nerve stimulation<br>|
| Sham Comparator: Sham device<br>60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device | Device: CEFALY Placebo<br>* Placebo external trigeminal nerve stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score 1-hour | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue Medication 2 Hours | Number of patients not having required rescue medication at 2 hours | 2 hours | 
| Pain Score 2 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used) | 2 hours | 
| Rescue Medication 24 Hours | Number of patients not having required rescue medication within 24 hours | 24 hours | 
| Pain Score 24 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used) | 24 hours |