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Trial record 2 of 13 for:    cefaly

Acute Treatment of Migraine Using the CEFALY Device

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ClinicalTrials.gov Identifier: NCT02411513
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

Brief Summary:
The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.

Condition or disease Intervention/treatment Phase
Migraine Device: CEFALY Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-trial on the Acute Treatment of Migraine Using the CEFALY Device
Study Start Date : April 2015
Actual Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active
60 minutes of CEFALY stimulation as acute treatment of an on-going attack
Device: CEFALY



Primary Outcome Measures :
  1. Change of pain intensity at 1 hour (VAS score) [ Time Frame: 1 hour ]
    Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11


Secondary Outcome Measures :
  1. Change of pain intensity at 2 hours (VAS score) [ Time Frame: 2 hours ]
    Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

  2. Patients with no need of medication at 2 hours [ Time Frame: 2 hours ]
    Percentage of patients not having required rescue medication after 2 hours

  3. Patients with no need of medication at 24 hours [ Time Frame: 24 hours ]
    Percentage of patients not having required rescue medication after 2 hours



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
  • The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.

Exclusion Criteria:

  • Pregnant women
  • Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head in the prior 4 months
  • Patients having received supraorbital nerve blocks in the prior 4 months
  • Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
  • Patients with only temporal or occipital headaches
  • Patients taking opioid medications
  • Patients having taken abortive migraine medication in the prior 3 hours
  • Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started).
  • Implanted metal or electrical devices in the head
  • Cardiac pacemaker or implanted or wearable defibrillator

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): NCT02411513


Locations
United States, New York
Columbia University Headache Center
New York, New York, United States, 10019
Sponsors and Collaborators
Cefaly Technology

Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT02411513     History of Changes
Other Study ID Numbers: 50208
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases