Clinical trial NCT02342743: Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Official title: Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2015-01-21
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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:

1. Women: Pregnant, lactating or \<6 months post partum
2. 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.
3. For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
4. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
5. A Beck Depression Inventory score of \>24 at baseline
6. Psychiatric disorders that could have interfered with study participation
7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

Primary outcomes:
measure: Change From Baseline in Frequency of Headache Days
timeFrame: End of baseline period and end of 12 weeks treatment period
measure: Change From Baseline in Acute Medication Intake
timeFrame: End of baseline period and end of 12 weeks treatment period
Secondary outcomes:
measure: Change in Frequency of Migraine Days
timeFrame: End of baseline period and end of 12 weeks treatment period
measure: Change in Frequency of Moderate/Severe Headache Days
timeFrame: End of baseline period and end of 12 weeks treatment period
measure: Change in Monthly Cumulative Headache Hours
timeFrame: End of baseline period and end of 12 weeks treatment period
measure: Change in Frequency of Headache Episodes
timeFrame: End of baseline period and end of 12 weeks treatment period
measure: 50% Responder Rate for Migraine Days
timeFrame: End of the 12 weeks treatment period
measure: Change in the Average Headache Intensity
timeFrame: End of baseline period and end of 12 weeks treatment period
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus - Department of Neurology
state: Colorado
Study officials:
affiliation: Department of Neurology, University of Colorado Anschutz Medical Campus
name: Marius Birlea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cefaly Technology
name: Pierre Rigaux
role: STUDY_DIRECTOR
References: