Migraine has been ranked as the second most disabling neurological disorder in the worldwide. Medication or nonpharmacological treatments are all reasonable options for the prevention. Oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (SNS) was reported to be valuable for migraine acute treatment and even the prevention. As a new nonpharmacological therapeutic method, whether SNS is equivalent to topiramate is still unknown. The aim of the present study was to compare their effects in a cohort of migraine patients. After diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either SNS or topiramate, and were followed up prospectively. After a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. At least the following assessments will be performed: (1) Change from baseline in the number of migraine days during the 3 observing months; (2) Change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. Comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of SNS versus topiramate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
SNS devices (DJTT-Ib, Hengyang Dajing Medical Instrument Technology Co., Ltd.) Stimulation electrodes are placed on the bilateral forehead, covering the supratrochlear and supraorbital nerves. The stimulus parameters are set as follows: pulse width 300 μsec, frequency 60 Hz, pulse duration μsec, increasing current peaked at 14 min with 16 mA. Patients receive SNS treatment daily for 20 min, no lease than 5 per week, last for 4 weeks.
Topiramate 25Mg Tab (Tuotai Pian, Xian Janssen Pharmaceutical Ltd.) are prescribed to participates by one neurologist. Participates are asked to take 25mg oral per day in a fixed time usually in the morning.
Wensheng Qu
Wuhan, Hubei, China
RECRUITINGmigraine days
Change from baseline in the number of migraine days during the 3 observing months
Time frame: during the 3 observing months
moderate/ severe headache days
Change from baseline in the number of moderate/ severe headache days over the 3 observing months
Time frame: over the 3 observing months
50% responder rate
50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month
Time frame: during the first treating 1 month
Averaged migraine days
Averaged migraine days per 4 weeks
Time frame: during the 3 observing months
migraine attacks
Number of migraine attacks per 4 weeks
Time frame: during the 3 observing months
Cumulative pain hours
Cumulative hours per 4 weeks of moderate/severe pain (Suggested by visual analogue scale)
Time frame: during the 3 observing months
bothersome symptoms
Effect on the most bothersome symptoms (anorexia, nausea, vomiting, photophobia, phonophobia. Weakness and dizziness)
Time frame: during the 3 observing months
Migraine functional impact
Using Headache Impact Test-6 (HIT-6) questionnaire, migraine functional impact were evaluated per 4 weeks
Time frame: during the 3 observing months
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