The purpose of this study is to evaluate the efficacy and safety of treating migraine in the acute phase by applying the acute mode (program 1) of Elexir (trigeminal nerve electrical stimulator) to patients with migraine.
Written consent is obtained from the subjects before proceeding with this study. Afterwards, the selection/exclusion criteria are checked to determine whether they are suitable for participation in the study. Subjects who meet the final selection/exclusion criteria are randomly assigned and assigned to the test group or control group in a 1:1 ratio, clinical research coordinator will provide the subject with Investigational device to use at home and migraine diary, AE reporting form If migraine occurs within 8 weeks at home, the subject applies a investigational device (test device or control device) for 1 hour. A migraine diary is written after a migraine occurs and before starting a investigational device. A migraine diary is written 1 and 2 hours after the start of application of the investigational device, and acute migraine treatment medications can be taken from that point on. Then, the subject writes migraine diary again 24 hours after starting to apply the investigational device. Subjects who have applied the investigational device must visit the institution within 7 days after application and return the investigational device and the migraine headache. If a subject does not occure a migraine within an 8-week period, subject must visit the institution and return the investigational device and migraine diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
The Elexir is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as Trigeminal Nerve Stimulation. The Elexir will deliver trigeminal nerve stimulation.
The sham device will deliver sham trigeminal nerve stimulation.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGUijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, South Korea
RECRUITINGChanges in VAS score
Check the change in VAS socre 1 hour after beginning of the TNS session. The VAS scale consists of a total of 11 points, and the higher the score, the greater the pain.
Time frame: 1 hour after beginning of the TNS session.
Pain Freedom
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 1hour, 2 hours after beginning of the TNS session.
Time frame: 1 hour, 2 hours after beginning of the TNS session.
Most Bothersome Migraine-associated Symptom Freedom
The percentage of patients with absence, at 1 hour, 2 hours after the beginning of the TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Time frame: 1 hour, 2 hours after beginning of the TNS session.
Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 1 hour, 2 hours after beginning of the TNS session.
Time frame: 1 hour, 2 hours after beginning of the TNS session
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 1 hour, 2 hours after beginning of the TNS session.
Time frame: 1 hour, 2 hours beginning of the TNS session
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after beginning of the TNS session.
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Time frame: 2-24 hours after beginning of the TNS session
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the TNS session.
Time frame: 24 hours after beginning of the TNS session
Sustained Pain Relief at 24 Hours
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the TNS session.
Time frame: 24 hours after beginning of the TNS session
Changes in headache intensity
Check the change in Likert Scale 1 hour, 2 hours, 24 hours after beginning of the TNS session.
Time frame: 1 hour, 2 hours, 24 hours after beginning of the TNS session
Rate of change in VAS score
Check the rate of change in VAS socre 1 hour after beginning of the TNS session.
Time frame: 1 hour after beginning of the TNS session