Acute Treatment of Migraine Using the CEFALY Device

Phase 1

Completed

• Conditions: Migraine
• Interventions: Device: CEFALY

• Registration Number: NCT02411513
• Lead Sponsor: Cefaly Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-31
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-08
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	CEFALY	60 minutes of CEFALY stimulation as acute treatment of an on-going attack

Primary Outcome Measures

Name	Time	Method
Change of pain intensity at 1 hour (VAS score)	1 hour	Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

Secondary Outcome Measures

Name	Time	Method
Change of pain intensity at 2 hours (VAS score)	2 hours	Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11
Patients with no need of medication at 2 hours	2 hours	Percentage of patients not having required rescue medication after 2 hours
Patients with no need of medication at 24 hours	24 hours	Percentage of patients not having required rescue medication after 2 hours

Trial Locations

Locations (1)

Columbia University Headache Center; 🇺🇸 New York, New York, United States