Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note