Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2016-02-01
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active device
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
CEFALY Active
Active external trigeminal nerve stimulation
Sham device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
CEFALY Placebo
Placebo external trigeminal nerve stimulation
Interventions
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CEFALY Active
Active external trigeminal nerve stimulation
CEFALY Placebo
Placebo external trigeminal nerve stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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®
18 Years
65 Years
ALL
No
Sponsors
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Cefaly Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Chou, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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50213
Identifier Type: -
Identifier Source: org_study_id
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