Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine
Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
Summary
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.