Acute Treatment of Migraine With e-TNS (ACME)

Cefaly Technology

Status

Completed

Conditions

Migraine

Treatments

Device: CEFALY Active

Device: CEFALY Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02590939

50213

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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®