Acute Treatment of Migraine Using the CEFALY Device

Cefaly Technology

Status and phase

Completed

Phase 1

Conditions

Migraine

Treatments

Device: CEFALY

Study type

Interventional

Funder types

Industry

Identifiers

NCT02411513

50208

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with a history of episodic or chronic migraine with or without aura, 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)
The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.

Exclusion criteria

Pregnant women
Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head 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 headaches
Patients taking opioid medications
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 while the neurostimulation has already started).
Implanted metal or electrical devices in the head
Cardiac pacemaker or implanted or wearable defibrillator