Acute Treatment of Migraine With e-TNS

Migraine Clinical Trial

— ACME  

Official title:

Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590939
• Other study ID #: 50213
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2018
• Source: Cefaly Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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®

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• CEFALY Active
Active external trigeminal nerve stimulation
• CEFALY Placebo
Placebo external trigeminal nerve stimulation

Locations

Country	Name	City	State
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical 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	Pain Score 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	1 hour
Secondary	Rescue Medication 2 Hours	Number of patients not having required rescue medication at 2 hours	2 hours
Secondary	Pain Score 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)	2 hours
Secondary	Rescue Medication 24 Hours	Number of patients not having required rescue medication within 24 hours	24 hours
Secondary	Pain Score 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)	24 hours