Acute Treatment of Migraine With e-TNS

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02590939

Run by

Cefaly Technology

People needed

106

Starts

2016-02-01

Expected to finish

2017-03-31

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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®

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Rowe Neurology Institute — Lenexa, Kansas, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.