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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
Active external trigeminal nerve stimulation
Placebo external trigeminal nerve stimulation
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
Pain Score 1-hour
Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline
Time frame: 1 hour
Rescue Medication 2 Hours
Number of patients not having required rescue medication at 2 hours
Time frame: 2 hours
Pain Score 2 Hours
Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)
Time frame: 2 hours
Rescue Medication 24 Hours
Number of patients not having required rescue medication within 24 hours
Time frame: 24 hours
Pain Score 24 Hours
Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)
Time frame: 24 hours
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