Acute Treatment of Migraine Using the CEFALY Device

December 3, 2015 updated by: Cefaly Technology

Open-trial on the Acute Treatment of Migraine Using the CEFALY Device

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Columbia University Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
Patients with no need of medication at 2 hours
Time Frame: 2 hours
Percentage of patients not having required rescue medication after 2 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cefaly Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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