Clinical trial NCT05516251: Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine
Official title: Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine: A Prospective, Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine, Classic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: migraine days
timeFrame: during the 3 observing months
measure: moderate/ severe headache days
timeFrame: over the 3 observing months
measure: 50% responder rate
timeFrame: during the first treating 1 month
Secondary outcomes:
measure: Averaged migraine days
timeFrame: during the 3 observing months
measure: migraine attacks
timeFrame: during the 3 observing months
measure: Cumulative pain hours
timeFrame: during the 3 observing months
measure: bothersome symptoms
timeFrame: during the 3 observing months
measure: Migraine functional impact
timeFrame: during the 3 observing months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wensheng Qu
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhiyuan Yu
role: STUDY_DIRECTOR
References:
citation: Riederer F, Penning S, Schoenen J. Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly(R) Device for Migraine Prevention: A Review of the Available Data. Pain Ther. 2015 Oct 14;4(2):135-47. doi: 10.1007/s40122-015-0039-5. Online ahead of print.
citation: Ordas CM, Cuadrado ML, Pareja JA, de-Las-Casas-Camara G, Gomez-Vicente L, Torres-Gaona G, Venegas-Perez B, Alvarez-Marino B, Diez Barrio A, Pardo-Moreno J. Transcutaneous Supraorbital Stimulation as a Preventive Treatment for Chronic Migraine: A Prospective, Open-Label Study. Pain Med. 2020 Feb 1;21(2):415-422. doi: 10.1093/pm/pnz119.
citation: Vikelis M, Dermitzakis EV, Spingos KC, Vasiliadis GG, Vlachos GS, Kararizou E. Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study. BMC Neurol. 2017 May 18;17(1):97. doi: 10.1186/s12883-017-0869-3.