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Acute Treatment of Migraine Using the CEFALY Device

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

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date December 4, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • 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
  • Patients with no need of medication at 2 hours [ Time Frame: 2 hours ]
    Percentage of patients not having required rescue medication after 2 hours
  • Patients with no need of medication at 24 hours [ Time Frame: 24 hours ]
    Percentage of patients not having required rescue medication after 2 hours
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • 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
  • Patients with no need of medication [ Time Frame: 2 hours ]
    Percentage of patients not having required rescue medication after 2 hours
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Treatment of Migraine Using the CEFALY Device
Official Title  ICMJE Open-trial on the Acute Treatment of Migraine Using the CEFALY Device
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Device: CEFALY
Study Arms  ICMJE Experimental: Active
60 minutes of CEFALY stimulation as acute treatment of an on-going attack
Intervention: Device: CEFALY
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02411513
Other Study ID Numbers  ICMJE 50208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cefaly Technology
Study Sponsor  ICMJE Cefaly Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cefaly Technology
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP