N/A Completed N=106 Randomized Triple-blind Treatment

Acute Treatment of Migraine With e-TNS

Migraine

Source: ClinicalTrials.gov NCT02590939 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcomePrimary: Pain Score 1-hour — -59; -30 percent change — p=<0.0001

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score 1-hour	-3.46; -1.78	<0.0001 sig
SECONDARY Rescue Medication 2 Hours	3; 2; 44; 50; 5; 2	0.666
SECONDARY Pain Score 2 Hours	-2.87; -1.85	0.028 sig
SECONDARY Rescue Medication 24 Hours	18; 21; 27; 30; 7; 3	1
SECONDARY Pain Score 24 Hours	-3.46; -2.38	0.062

Eligibility Criteria

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®

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02590939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.