Acute Treatment of Migraine With e-TNS

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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®

Primary Outcome Measures

Name	Time	Method
Pain Score 1-hour	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

Secondary Outcome Measures

Name	Time	Method
Pain Score 2 Hours	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)
Rescue Medication 24 Hours	24 hours	Number of patients not having required rescue medication within 24 hours
Pain Score 24 Hours	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)
Rescue Medication 2 Hours	2 hours	Number of patients not having required rescue medication at 2 hours

Locations (3): Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Rowe Neurology Institute
🇺🇸
Lenexa, Kansas, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States