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Completed

NCT Number: NCT02590939

Acute Treatment of Migraine With e-TNS

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.

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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

Not applicable

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

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

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®

Treatment and study plan

CEFALY Active

Device

Active external trigeminal nerve stimulation

CEFALY Placebo

Device

Placebo external trigeminal nerve stimulation

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cefaly Technology

Industry

Registry information

Official study title

Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device

Acronym: ACME

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2015
Registry last updated
Jun 6, 2018

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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