Migraine, ClassicNCT05516251
Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine
A study testing Transcutaneous Supraorbital Nerve Stimulator and Topiramate 25Mg Tab in people with Migraine, Classic, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Classic
- What is being tested?
- Transcutaneous Supraorbital Nerve Stimulator and Topiramate 25Mg Tab
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wensheng Qu
Wuhan, Hubei, 430030
Wensheng Qu, MD, 18971622660, qws0309@163.com
About this study
Official title: 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.
- Conditions
- Migraine, Classic
- Being tested
- Transcutaneous Supraorbital Nerve Stimulator, Topiramate 25Mg Tab
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Supraorbital Nerve StimulatorDevice
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.
Topiramate 25Mg TabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Active comparator | Not described Receives: Drug: Topiramate 25Mg Tab |
| Transcutaneous Supraorbital Nerve Stimulator | Experimental | Not described Receives: Device: Transcutaneous Supraorbital Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
migraine days
Change from baseline in the number of migraine days during the 3 observing months
Measured: 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
Measured: 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
Measured: during the first treating 1 month
Secondary outcomes (5)
Averaged migraine days
Averaged migraine days per 4 weeks
Measured: during the 3 observing months
migraine attacks
Number of migraine attacks per 4 weeks
Measured: during the 3 observing months
Cumulative pain hours
Cumulative hours per 4 weeks of moderate/severe pain (Suggested by visual analogue scale)
Measured: during the 3 observing months
bothersome symptoms
Effect on the most bothersome symptoms (anorexia, nausea, vomiting, photophobia, phonophobia. Weakness and dizziness)
Measured: during the 3 observing months
Migraine functional impact
Using Headache Impact Test-6 (HIT-6) questionnaire, migraine functional impact were evaluated per 4 weeks
Measured: during the 3 observing months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Oct 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine, ClassicStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyuan Yu, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516251
- Sponsor's protocol ID
- 2021-S203
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26467451Ordas 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.
PubMed 31131857Vikelis 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.
PubMed 28521762
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine: A Prospective, Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT05516251
- Acronym / sponsor ID
- 2021-S203
- Conditions
- Migraine, Classic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Active comparator | Drug: Topiramate 25Mg Tab |
| Transcutaneous Supraorbital Nerve Stimulator | Experimental | Device: Transcutaneous Supraorbital Nerve Stimulator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Supraorbital Nerve StimulatorSNS 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. | Device | Transcutaneous Supraorbital Nerve Stimulator |
| Topiramate 25Mg TabTopiramate 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. | Drug | Topiramate |
Primary outcome
migraine days
Time frame: during the 3 observing months
Change from baseline in the number of migraine days during the 3 observing months
moderate/ severe headache days
Time frame: over the 3 observing months
Change from baseline in the number of moderate/ severe headache days over the 3 observing months
50% responder rate
Time frame: during the first treating 1 month
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
5 secondary outcomes
Averaged migraine days
Time frame: during the 3 observing months
migraine attacks
Time frame: during the 3 observing months
Cumulative pain hours
Time frame: during the 3 observing months
bothersome symptoms
Time frame: during the 3 observing months
Migraine functional impact
Time frame: during the 3 observing months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Results publication: PubMed 26467451Riederer 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.
- Results publication: PubMed 31131857Ordas 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.
- Results publication: PubMed 28521762Vikelis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyuan Yu study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Supraorbital Nerve Stimulator and Topiramate 25Mg Tab in people with Migraine, Classic, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wensheng Qu, MD (02783663337, qws0309@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
migraine days (time frame: during the 3 observing months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516251, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.