Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Refractory Migraine

NCT03125525 | Completed FDA Device

• 1 other identifier: CorfuHC
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Keywords

migraine; transcutaneous; supraorbital; nerve; stimulation

Outcome Measures

Primary Outcomes (1)

• Change in headache days

  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.

  4 months

Secondary Outcomes (1)

• Patient overall satisfaction

  3 months

Study Arms (1)

Active treatment patients

Patients using Cefaly device on routine daily basis

Device: Cefaly device

Interventions

Cefaly device 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

Also known as: transcutaneous supraorbital nerve stimulation with Cefaly

Active treatment patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \- No

Sponsors & Collaborators

• Corfu Headache Clinic: lead

Related Publications (2)

• 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 BACKGROUND

• 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 DERIVED

Related Links

• Cefaly® Technology. (Last accessed 27 Jul. 16)

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Michail Vikelis

  Meditteraneo Hospital of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: January 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04