Acute Treatment of Migraine Using the CEFALY Device

Migraine Clinical Trial

Official title:

Open-trial on the Acute Treatment of Migraine Using the CEFALY Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411513
• Other study ID #: 50208
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2015
• Last updated: December 3, 2015
• Start date: April 2015

Study information

• Verified date: December 2015
• Source: Cefaly Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• CEFALY

Locations

Country	Name	City	State
United States	Columbia University Headache Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cefaly Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain intensity at 1 hour (VAS score)	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	1 hour	No
Secondary	Change of pain intensity at 2 hours (VAS score)	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	2 hours	No
Secondary	Patients with no need of medication at 2 hours	Percentage of patients not having required rescue medication after 2 hours	2 hours	No
Secondary	Patients with no need of medication at 24 hours	Percentage of patients not having required rescue medication after 2 hours	24 hours	No