Acute Treatment of Migraine With e-TNS (ACME)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: CEFALY Active; Device: CEFALY Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Kansas
    • Lenexa, Kansas, United States, 66214-9836
      • Rowe Neurology Institute
  • New York
    • New York, New York, United States, 10019
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active device; 60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device	Device: CEFALY Active; Active external trigeminal nerve stimulation
Sham Comparator: Sham device; 60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device	Device: CEFALY Placebo; Placebo external trigeminal nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Medication 2 Hours	Number of patients not having required rescue medication at 2 hours	2 hours
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
Rescue Medication 24 Hours	Number of patients not having required rescue medication within 24 hours	24 hours
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

Collaborators and Investigators

• Sponsor: Cefaly Technology
• Investigators: Principal Investigator: Denise Chou, M.D., Columbia University

Publications and helpful links

General Publications

• Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019 Jan;39(1):3-14. doi: 10.1177/0333102418811573. Epub 2018 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 50213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No