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Acute Treatment of Migraine With e-TNS (ACME)

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ClinicalTrials.gov Identifier: NCT02590939
Recruitment Status : Completed
First Posted : October 29, 2015
Results First Posted : April 9, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

Study Description
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Brief Summary:
The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.

Condition or disease Intervention/treatment Phase
Migraine Device: CEFALY Active Device: CEFALY Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active device
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
 Device: CEFALY Active
Active external trigeminal nerve stimulation
Sham Comparator: Sham device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
 Device: CEFALY Placebo
Placebo external trigeminal nerve stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Pain Score 1-hour [ Time Frame: 1 hour ]
    Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline


Secondary Outcome Measures :
  1. Rescue Medication 2 Hours [ Time Frame: 2 hours ]
    Number of patients not having required rescue medication at 2 hours

  2. Pain Score 2 Hours [ Time Frame: 2 hours ]
    Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)

  3. Rescue Medication 24 Hours [ Time Frame: 24 hours ]
    Number of patients not having required rescue medication within 24 hours

  4. Pain Score 24 Hours [ Time Frame: 24 hours ]
    Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)


Eligibility Criteria
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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:

  • History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction)
  • Having a migraine attack lasting at least 3 hours
  • Migraine pain intensity stabilized for at least 1 hour
  • Frontal, retro-, or peri- orbital headache.

Exclusion Criteria:

  • Pregnant women
  • Patients having received Botox treatment 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 headache
  • Patients using opioid medication
  • 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 if they are unable to tolerate the first 5 minutes of neurostimulation).
  • Implanted metal or electrical devices in the head
  • Cardiac pacemaker or implanted or wearable defibrillator
  • Patient having had a previous experience with Cefaly®
Contacts and Locations
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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): NCT02590939


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Kansas
Rowe Neurology Institute
Lenexa, Kansas, United States, 66214-9836
United States, New York
Columbia University Medical Center
New York, New York, United States, 10019
Sponsors and Collaborators
Cefaly Technology
Investigators
Principal Investigator: Denise Chou, M.D. Columbia University
  Study Documents (Full-Text)

Documents provided by Cefaly Technology:
Study Protocol and Statistical Analysis Plan  [PDF] July 11, 2016

More Information
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Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT02590939     History of Changes
Other Study ID Numbers: 50213
First Posted: October 29, 2015    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: June 6, 2018
Last Verified: May 2018

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