Acute Treatment of Migraine With e-TNS

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Device: CEFALY Placebo; Device: CEFALY Active

• Registration Number: NCT02590939
• Lead Sponsor: Cefaly Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2016-02-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Results First Submitted: 2018-02-07
• Results First Submitted QC: 2018-03-08
• Results First Posted: 2018-04-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham device	CEFALY Placebo	60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
Active device	CEFALY Active	60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device

Primary Outcome Measures

Name	Time	Method
Pain Score 1-hour	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

Secondary Outcome Measures

Name	Time	Method
Rescue Medication 2 Hours	2 hours	Number of patients not having required rescue medication at 2 hours
Pain Score 2 Hours	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)
Rescue Medication 24 Hours	24 hours	Number of patients not having required rescue medication within 24 hours
Pain Score 24 Hours	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)

Trial Locations

Locations (3)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

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

Rowe Neurology Institute; 🇺🇸 Lenexa, Kansas, United States