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Acute Treatment of Migraine With e-TNS (ACME)

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEFALY Active
CEFALY Placebo
Sponsored by
Cefaly Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®

Sites / Locations

  • Yale University School of Medicine
  • Rowe Neurology Institute
  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active device

Sham device

Arm Description

60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device

60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device

Outcomes

Primary Outcome Measures

Pain Score 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

Rescue Medication 2 Hours
Number of patients not having required rescue medication at 2 hours
Pain Score 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)
Rescue Medication 24 Hours
Number of patients not having required rescue medication within 24 hours
Pain Score 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)

Full Information

First Posted
October 28, 2015
Last Updated
May 4, 2018
Sponsor
Cefaly Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02590939
Brief Title
Acute Treatment of Migraine With e-TNS
Acronym
ACME
Official Title
Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cefaly Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active device
Arm Type
Experimental
Arm Description
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
Arm Title
Sham device
Arm Type
Sham Comparator
Arm Description
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
Intervention Type
Device
Intervention Name(s)
CEFALY Active
Intervention Description
Active external trigeminal nerve stimulation
Intervention Type
Device
Intervention Name(s)
CEFALY Placebo
Intervention Description
Placebo external trigeminal nerve stimulation
Primary Outcome Measure Information:
Title
Pain Score 1-hour
Description
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
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Rescue Medication 2 Hours
Description
Number of patients not having required rescue medication at 2 hours
Time Frame
2 hours
Title
Pain Score 2 Hours
Description
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)
Time Frame
2 hours
Title
Rescue Medication 24 Hours
Description
Number of patients not having required rescue medication within 24 hours
Time Frame
24 hours
Title
Pain Score 24 Hours
Description
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)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Chou, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214-9836
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30449151
Citation
Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019 Jan;39(1):3-14. doi: 10.1177/0333102418811573. Epub 2018 Nov 17.
Results Reference
derived

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Acute Treatment of Migraine With e-TNS

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