MigraineACMENCT02590939

Acute Treatment of Migraine With e-TNS

A study testing CEFALY Active in people with Migraine, run by Cefaly Technology at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: CEFALY Active
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 3 sitesUnited States
Study dates: 1 Feb 2016to 31 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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®

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Rowe Neurology Institute
Lenexa, Kansas, 66214-9836
Yale University School of Medicine
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10019

Other trials in United States

About this study

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

Conditions: Migraine
Being tested: CEFALY Active, CEFALY Placebo
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CEFALY ActiveDevice
Active external trigeminal nerve stimulation
CEFALY PlaceboDevice
Placebo external trigeminal nerve stimulation

Study groups in NCT02590939
Study group	Role	What they receive
Active device	Experimental	60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device Receives: Device: CEFALY Active
Sham device	Sham comparator	60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device Receives: Device: CEFALY Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 hour

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201631 Mar 2017

First posted29 Oct 2015 (estimated)
Study start1 Feb 2016
Primary completion31 Mar 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02590939
Sponsor's protocol ID: 50213
Acronym: ACME
Status last verified: May 2018
First submitted: 28 Oct 2015
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ye Y, Xie X, Huang H, Zhang H, Yu Y, Qu W. Efficacy and safety of transcutaneous supraorbital nerve stimulation versus topiramate for migraine prevention: a non-inferiority randomized trial. J Headache Pain. 2026 Apr 14;27(1):143. doi: 10.1186/s10194-026-02367-2.
PubMed 41981402
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.
PubMed 30449151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Marine Lipids Ease Painful TMD
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
ClinicalTrials.gov ID: NCT02590939
Acronym / sponsor ID: ACME / 50213
Conditions: Migraine
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Cefaly TechnologyIndustry (pharma, biotech, devices)
Study start: 1 Feb 2016 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 29 Oct 2015 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Active device	Experimental	Device: CEFALY Active60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
Sham device	Sham comparator	Device: CEFALY Placebo60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CEFALY ActiveActive external trigeminal nerve stimulation	Device	Active device
CEFALY PlaceboPlacebo external trigeminal nerve stimulation	Device	Sham device

Primary outcome

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

4 secondary outcomes

Rescue Medication 2 Hours
Time frame: 2 hours
Pain Score 2 Hours
Time frame: 2 hours
Rescue Medication 24 Hours
Time frame: 24 hours
Pain Score 24 Hours
Time frame: 24 hours

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Device	52	47
Sham Device	54	52

Primary outcome: Pain Score 1-hour

Time frame: 1 hour. Mean (Standard Deviation). Unit: percent change

Measure	Active Device n = 52	Sham Device n = 54
Value	-59 (35)	-30 (31)

Active Device vs Sham Device: p <0.0001, Wilcoxon (Mann-Whitney)

Primary outcome: Pain Score 1-hour

Time frame: 1 hour. Mean (Standard Deviation). Unit: units on a scale

Measure	Active Device n = 52	Sham Device n = 54
Value	-3.46 (2.32)	-1.78 (1.89)

Active Device vs Sham Device: p <0.0001, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours following the beginning of the treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Device	0 of 52 (0%)	1 of 52 (1.9%)	0 of 52
Sham Device	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41981402Ye Y, Xie X, Huang H, Zhang H, Yu Y, Qu W. Efficacy and safety of transcutaneous supraorbital nerve stimulation versus topiramate for migraine prevention: a non-inferiority randomized trial. J Headache Pain. 2026 Apr 14;27(1):143. doi: 10.1186/s10194-026-02367-2.
Derived from this study: PubMed 30449151Chou 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.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Denise Chou, M.D. principal investigator

Columbia University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CEFALY Active in people with Migraine, run by Cefaly Technology at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score 1-hour (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02590939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.