Clinical trial NCT02590939: Acute Treatment of Migraine With e-TNS
Official title: Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Pain Score 1-hour
timeFrame: 1 hour
Secondary outcomes:
measure: Rescue Medication 2 Hours
timeFrame: 2 hours
measure: Pain Score 2 Hours
timeFrame: 2 hours
measure: Rescue Medication 24 Hours
timeFrame: 24 hours
measure: Pain Score 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Denise Chou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.