Migraine
Conditions
Brief summary
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.
Interventions
DEVICECEFALY
Sponsors
Cefaly Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of pain intensity at 1 hour (VAS score) | 1 hour | Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of pain intensity at 2 hours (VAS score) | 2 hours | Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 |
| Patients with no need of medication at 2 hours | 2 hours | Percentage of patients not having required rescue medication after 2 hours |
| Patients with no need of medication at 24 hours | 24 hours | Percentage of patients not having required rescue medication after 2 hours |
Countries
United States
Outcome results
None listed