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Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Refractory Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03125525
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):

Brief Summary:

Migraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation (t-SMS), 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 non-tolerant to topiramate prophylaxis.

Patients were followed prospectively after having been diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment and having consented to receive preventive treatment with Cefaly® according to their treating physician's suggestion. A 1-month period of baseline observation was followed by a 3-month period of active treatment with transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.

Condition or disease Intervention/treatment
Migraine Device: Cefaly device

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Patients With Refractory Migraine or With Migraine and Intolerance to Topiramate: a Prospective Exploratory Clinical Study
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Group/Cohort Intervention/treatment
Active treatment patients
Patients using Cefaly device on routine daily basis
Device: Cefaly device
Use of Cefaly based upon the protocol of the approval study of the device, in which it is used once every day on the migraine prevention program
Other Name: transcutaneous supraorbital nerve stimulation with Cefaly

Primary Outcome Measures :
  1. Change in headache days [ Time Frame: 4 months ]

    Change in headache days, as recorded on a self-administered headache questionnaire, at 1st, 2nd and 3rd month of active treatment comparing to the baseline observation.

    Linear Mixed Models were performed, with patients modelled as a random effect, time (study month), and their interaction modelled as fixed effects.

    Statistical significance was set to the observed level of 5%. All statistical analyses were performed using STATA v.13.

Secondary Outcome Measures :
  1. Patient overall satisfaction [ Time Frame: 3 months ]
    Patients resonse to the question "Are you satisfied with Cefaly® and wish to continue the treatment?"

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients non-respondint to preventive treatment of migraine with topiramate accepting to use Cefaly according to protocol proposed by their treating phycisian

Inclusion Criteria:

- Migraine according to the criteria of International Headache Society classification III lack of response or intolerance to topiramate. Patient's consent

Exclusion Criteria:

- No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125525

Sponsors and Collaborators
Corfu Headache Clinic
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Study Director: Michail Vikelis Meditteraneo Hospital of Athens
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KONSTANTINOS SPINGOS, Dr., Corfu Headache Clinic
ClinicalTrials.gov Identifier: NCT03125525    
Other Study ID Numbers: CorfuHC
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by KONSTANTINOS SPINGOS, Corfu Headache Clinic:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases