Acute Treatment of Migraine With e-TNS
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/8/2018 |
| Start Date: | February 1, 2016 |
| End Date: | March 31, 2017 |
Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
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.
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.
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®
We found this trial at
3
sites
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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