Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

NCT05516251 | Unknown DMC

• 1 other identifier: 2021-S203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Averaged migraine days

  during the 3 observing months

• migraine attacks

  during the 3 observing months

• Cumulative pain hours

  during the 3 observing months

• bothersome symptoms

  during the 3 observing months

• Migraine functional impact

  during the 3 observing months

Study Arms (2)

Topiramate

ACTIVE COMPARATOR

Drug: Topiramate 25Mg Tab

Transcutaneous Supraorbital Nerve Stimulator

EXPERIMENTAL

Device: Transcutaneous Supraorbital Nerve Stimulator

Interventions

Transcutaneous Supraorbital Nerve Stimulator 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.

Transcutaneous Supraorbital Nerve Stimulator

Topiramate 25Mg Tab 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.

Topiramate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Wensheng Qu

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 26467451 RESULT

• 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.

  PMID: 31131857 RESULT

• 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.

  PMID: 28521762 RESULT

MeSH Terms

Conditions

Migraine with Aura

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Zhiyuan Yu

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Wensheng Qu, MD

CONTACT

02783663337; qws0309@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 25, 2022
• Study Start: October 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

CN (1)