Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Study Overview
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Brief Summary
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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.

Official Title
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Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine: A Prospective, Randomized Comparative Study.

Conditions
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Migraine, Classic

Intervention / Treatment
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* Device: Transcutaneous Supraorbital Nerve Stimulator
* Drug: Topiramate 25Mg Tab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topiramate<br> | Drug: Topiramate 25Mg Tab<br>* 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.<br>|
| Experimental: Transcutaneous Supraorbital Nerve Stimulator<br> | Device: Transcutaneous Supraorbital Nerve Stimulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| migraine days | Change from baseline in the number of migraine days during the 3 observing months | 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 | 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 | during the first treating 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averaged migraine days | Averaged migraine days per 4 weeks | during the 3 observing months | 
| migraine attacks | Number of migraine attacks per 4 weeks | during the 3 observing months | 
| Cumulative pain hours | Cumulative hours per 4 weeks of moderate/severe pain (Suggested by visual analogue scale) | during the 3 observing months | 
| bothersome symptoms | Effect on the most bothersome symptoms (anorexia, nausea, vomiting, photophobia, phonophobia. Weakness and dizziness) | during the 3 observing months | 
| Migraine functional impact | Using Headache Impact Test-6 (HIT-6) questionnaire, migraine functional impact were evaluated per 4 weeks | during the 3 observing months |