Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine, Classic
• Intervention / Treatment: Drug: Topiramate 25Mg Tab; Device: Transcutaneous Supraorbital Nerve Stimulator

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wensheng Qu, MD; Phone Number: 02783663337; Email: qws0309@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Wensheng Qu
      • Contact: Wensheng Qu, MD; Phone Number: 18971622660; Email: qws0309@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topiramate	Drug: Topiramate 25Mg Tab; 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.
Experimental: Transcutaneous Supraorbital Nerve Stimulator	Device: Transcutaneous Supraorbital Nerve Stimulator; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Director: Zhiyuan Yu, Tongji Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine with Aura; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Topiramate
• Other Study ID Numbers: 2021-S203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No