Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

T

Tongji Hospital

Status

Enrolling

Conditions

Migraine, Classic

Treatments

Drug: Topiramate 25Mg Tab
Device: Transcutaneous Supraorbital Nerve Stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05516251
2021-S203

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Topiramate
Active Comparator group
Treatment:
Drug: Topiramate 25Mg Tab
Transcutaneous Supraorbital Nerve Stimulator
Experimental group
Treatment:
Device: Transcutaneous Supraorbital Nerve Stimulator

Trial contacts and locations

0

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Central trial contact

Wensheng Qu, MD

Data sourced from clinicaltrials.gov

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