Acute Treatment of Migraine Using the CEFALY Device
Completed · Phase 1
Conditions studied: Migraine
In brief
The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.
Key facts
- Study ID
- NCT02411513
- Run by
- Cefaly Technology
- People needed
- 30
- Starts
- 2015-04-01
- Last updated by the study team
- 2015-12-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
- The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.
You may not qualify if…
- Pregnant women
- Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head 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 headaches
- Patients taking opioid medications
- 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 while the neurostimulation has already started).
- Implanted metal or electrical devices in the head
- Cardiac pacemaker or implanted or wearable defibrillator
Where it is running
- Columbia University Headache Center — New York, New York, United States
Full record on ClinicalTrials.gov
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