Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

NCT ID: NCT05516251

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-09-30

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.

Conditions

Migraine, Classic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topiramate

Group Type: ACTIVE_COMPARATOR

Topiramate 25Mg Tab

Intervention Type: DRUG

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.

Transcutaneous Supraorbital Nerve Stimulator

Group Type: EXPERIMENTAL

Transcutaneous Supraorbital Nerve Stimulator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiyuan Yu

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

Wensheng Qu

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wensheng Qu, MD

Role: CONTACT

qws0309@126.com

02783663337

Facility Contacts

Wensheng Qu, MD

Role: primary

qws0309@163.com

18971622660

References

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.

Reference Type: RESULT

PMID: 26467451 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31131857 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28521762 (View on PubMed)

Other Identifiers

2021-S203

Identifier Type: -

Identifier Source: org_study_id