Evidence map›Paper›PMID 28521762›Full record

Trial reportBMC neurology2017

Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study.

Michail Vikelis, Emmanouil V Dermitzakis, Konstantinos C Spingos, Georgios G Vasiliadis, George S Vlachos, Evaggelia Kararizou

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03125525 completednot on this map

Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Patients With Refractory Migraine or With Migraine and Intolerance to Topiramate: a Prospective Exploratory Clinical Study

TypeobservationalSponsorCorfu Headache ClinicRan2016 to 2016Enrolled37ConditionsMigraineArmsCefaly device
NCT05516251 naunknown statusnot on this mapstarted 2021, after this paper: background citation

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

TypeinterventionalSponsorTongji HospitalRan2021 to 2023Enrolled200ConditionsMigraine, ClassicArmsTranscutaneous Supraorbital Nerve Stimulator, Topiramate 25Mg Tab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Non-Invasive Neuromodulation in the Treatment of Headache.Current neurology and neuroscience reports · 2025
    Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Neuromodulation for Chronic Daily Headache.Current pain and headache reports · 2022
    Review
  13. Review
  14. Article
  15. Peripheral Neuromodulation for the Management of Headache.Anesthesiology and pain medicine · 2020
    Review
  16. A new era in headache treatment.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Michail VikelisMediterraneo Hospital, Headache Clinic, Glyfada, Greece.
Emmanouil V DermitzakisGeniki Kliniki Euromedica, Department of Neurology, Thessaloniki, Greece.
Konstantinos C SpingosCorfu Headache Clinic, 13, Mitropolitou Methodiou str, 49100, Corfu, Greece. kcspigos@gmail.com.ORCID http://orcid.org/0000-0003-0774-8129
Georgios G VasiliadisGeniki Kliniki Euromedica, Department of Neurology, Thessaloniki, Greece.
George S VlachosMediterraneo Hospital, Headache Clinic, Glyfada, Greece.
Evaggelia KararizouHeadache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece.
Euromedica · GRNational and Kapodistrian University of Athens · GRCorfu General Clinic · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMigraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation, including the Cefaly® device, for the treatment of various types of pain is a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.

methodsA prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly® according to the treating physician's suggestion. A 1-month period of baseline observation was followed by a 3-month period of observation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.

resultsA small but statistically significant decline was shown over time in the number of days with headache (HA), the number of days with HA with intensity ≥5/10, and the number of days with use of acute medication after 3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent to continue treatment with Cefaly®. Compliance was higher among satisfied subjects compared to non-satisfied subjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.

conclusionThree-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not respond to topiramate.

trial registrationClinicalTrials NCT03125525 . Registered 21 April 2017.

Indexed as

AdultBiomedical ResearchChronic DiseaseFructoseHeadacheHumansMiddle AgedMigraine DisordersNeuroprotective AgentsPainPatient ComplianceProspective StudiesTopiramateTranscutaneous Electric Nerve StimulationTreatment FailureTreatment OutcomeFructoseNeuroprotective AgentsTopiramate

Identifiers

PMID28521762
PMCPMC5437420
OpenAlexW2614108880

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.