Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    200
  • sponsor
    Tongji Hospital
Updated on 7 October 2022

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.

Details
Condition Migraine, Classic
Treatment Transcutaneous Supraorbital Nerve Stimulator, Topiramate 25Mg Tab
Clinical Study IdentifierNCT05516251
SponsorTongji Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18-60 years old
Diagnosed with definite migraine (ICHD-3 code 1.1 or 1.2)
At least 2 migraine attacks per month during the past 3 months
Consent to participate in the study
No contraindications to associated treatments

Exclusion Criteria

Received preventive treatments during the previous 3 months
Definite other kinds of headache, especially tension-type, medication overuse and secondary headache (ICHD-3 code 8.2)
Severe neurological or psychiatric disorders
Severe primary systemic disorders including heart, brain, liver, kidney, and hematopoietic system
Women with pregnancy or lactation
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