Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Migraine, Classic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516251
• Other study ID #: 2021-S203
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Tongji Hospital
• Contact: Wensheng Qu, MD
• Phone: 02783663337
• Email: qws0309[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura
• Migraine, Classic

Intervention

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.

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.

Locations

Country	Name	City	State
China	Wensheng Qu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Ordás CM, Cuadrado ML, Pareja JA, de-Las-Casas-Cámara G, Gómez-Vicente L, Torres-Gaona G, Venegas-Pérez B, Álvarez-Mariño B, Diez Barrio A, Pardo-Moreno J. Transcutaneous Supraorbital Stimulation as a Preventive Treatment for Chronic Migraine: A Prospecti — View Citation

Riederer F, Penning S, Schoenen J. Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly(®) Device for Migraine Prevention: A Review of the Available Data. Pain Ther. 2015 Oct 14. [Epub ahead of print] — View 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 explor — View Citation

Outcome

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