Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

Study Overview
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Brief Summary
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The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Detailed Description
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The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Official Title
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Open-trial on the Prevention of Chronic Migraines With 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: Patients with a history of chronic migraine 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) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours. Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited Exclusion Criteria: Women: Pregnant, lactating or <6 months post partum For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period. For patients treated with Botox, no injection within 4 months before start of baseline or during the study. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache A Beck Depression Inventory score of >24 at baseline Psychiatric disorders that could have interfered with study participation Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Daily trigeminal nerve stimulation session of 20 minutes with CEFALY | Device: CEFALY<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Frequency of Headache Days | Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 
| Change From Baseline in Acute Medication Intake | Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frequency of Migraine Days | Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 
| Change in Frequency of Moderate/Severe Headache Days | Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 
| Change in Monthly Cumulative Headache Hours | Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 
| Change in Frequency of Headache Episodes | Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period | 
| 50% Responder Rate for Migraine Days | Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of the 12 weeks treatment period | 
| Change in the Average Headache Intensity | Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain). | End of baseline period and end of 12 weeks treatment period |