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OpenTrials
Completed

NCT Number: NCT02411513

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Headache Center

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEFALY

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cefaly Technology

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
First posted
Apr 8, 2015
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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