Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
60 minutes of CEFALY stimulation as acute treatment of an on-going attack
CEFALY
Interventions
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CEFALY
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Cefaly Technology
INDUSTRY
Responsible Party
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Locations
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Columbia University Headache Center
New York, New York, United States
Countries
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Other Identifiers
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50208
Identifier Type: -
Identifier Source: org_study_id