N/A
Completed N=73
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Source: ClinicalTrials.gov NCT02342743 ↗Enrolled (actual)
73
Serious AEs
1.7%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in Frequency of Headache Days — -3.12 days per 28-days — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Frequency of Headache Days |
-3.12 | <0.001 sig |
| PRIMARY Change From Baseline in Acute Medication Intake |
-8.11 | <0.001 sig |
| SECONDARY Change in Frequency of Migraine Days |
-3.35 | <0.001 sig |
| SECONDARY Change in Frequency of Moderate/Severe Headache Days |
-3.10 | <0.001 sig |
| SECONDARY Change in Monthly Cumulative Headache Hours |
-27.22 | 0.012 sig |
| SECONDARY Change in Frequency of Headache Episodes |
-3.12 | <0.001 sig |
| SECONDARY 50% Responder Rate for Migraine Days |
11 | — |
| SECONDARY Change in the Average Headache Intensity |
-0.12 | 0.030 sig |
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
- Women: Pregnant, lactating or 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)
Data sourced from ClinicalTrials.gov (NCT02342743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.