MigraineTEAMNCT03465904

A Phase III Trial of e-TNS for the Acute Treatment of Migraine

A study testing Verum Cefaly® Abortive Program device in people with Migraine, run by Cefaly Technology at 10 sites in United States.

Completed

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

Official record

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Trial summary

The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: Verum Cefaly® Abortive Program device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 607 participants
Where: 10 sitesUnited States
Study dates: 10 Apr 2018to 11 Jan 2019
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

Age from 18 to 65 on the day of signing the informed consent form
≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
Migraine onset before the age of 50
Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form)

Who cannot join

Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
Patient has more than 15 headache days per month
Patient having received supraorbital nerve blocks in the prior 4 months
Patient having received Botox treatment in the prior 4 months
Modification of a migraine prophylaxis treatment in the previous 3 months
Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month

Show all 14Show fewer

Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)
Patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence
Implanted metallic or electronic device in the head
Cardiac pacemaker or implanted or wearable defibrillator
Patient having had a previous experience with the Cefaly® device
Migraine Aura without headache
Patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (Visit 1)
Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Rapid Medical Research Inc.
Cleveland, Ohio, 44122
Pharmacology Research Institute
Encino, California, 91316
Clinical Research Consortium
Las Vegas, Nevada, 89119
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Yale University
New Haven, Connecticut, 06519
Rochester Clinical Research
Rochester, New York, 14609
Meridian Clinical Research (Rockville Neurology)
Rockville, Maryland, 20854
Meridian Clinical Research (Savannah Neurology)
Savannah, Georgia, 31406
Clinical Research Consortium
Tempe, Arizona, 85283
Palm Beach Research Center
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)

Read the detailed description

The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Conditions: Migraine
Being tested: Verum Cefaly® Abortive Program device, Sham Cefaly® Abortive Program device
Medical subject headings: Migraine Disorders

What participants receive

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

Verum Cefaly® Abortive Program deviceDevice
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
Sham Cefaly® Abortive Program deviceDevice
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.

Study groups in NCT03465904
Study group	Role	What they receive
Verum	Experimental	2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack Receives: Device: Verum Cefaly® Abortive Program device
Sham	Sham comparator	2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack Receives: Device: Sham Cefaly® Abortive Program device

What is being measured

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

Pain Freedom at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Measured: 2 hours

Secondary outcomes (5)

Pain Relief at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Measured: 2 hours
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Measured: 2-24 hours
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Measured: 24 hours
Sustained Pain Relief at 24 Hours
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Measured: 2-24 hours

Timeline

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

10 Apr 201811 Jan 2019

First posted14 Mar 2018
Study start10 Apr 2018
Primary completion11 Jan 2019
Study completion11 Jan 2019

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 607 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03465904
Sponsor's protocol ID: 51401
Acronym: TEAM
Status last verified: Nov 2024
First submitted: 8 Mar 2018
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Johnson MAL, Panza G, Kuruvilla DE. Migraine phases and treatment response: a post hoc analysis of participants with migraine with aura from the TEAM study. BMC Neurol. 2026 Jun 3. doi: 10.1186/s12883-026-05028-8. Online ahead of print.
PubMed 42231198
Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.
PubMed 35332216

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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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
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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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)
ClinicalTrials.gov ID: NCT03465904
Acronym / sponsor ID: TEAM / 51401
Conditions: Migraine
Study type: Interventional
Recruitment status: Completed
Enrolment: 607 participants (actual)
Lead sponsor: Cefaly TechnologyIndustry (pharma, biotech, devices)
Study start: 10 Apr 2018 (actual)
Primary completion: 11 Jan 2019 (actual)
Study completion: 11 Jan 2019 (actual)
First posted: 14 Mar 2018 (actual)
Results: Posted 1 Jul 2019

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Verum	Experimental	Device: Verum Cefaly® Abortive Program device2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham	Sham comparator	Device: Sham Cefaly® Abortive Program device2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack

Who may qualify

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

Key inclusion criteria (6 listed)

Age from 18 to 65 on the day of signing the informed consent form
≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
Migraine onset before the age of 50
Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent

Key exclusion criteria (14 listed)

Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
Patient has more than 15 headache days per month
Patient having received supraorbital nerve blocks in the prior 4 months
Patient having received Botox treatment in the prior 4 months
Modification of a migraine prophylaxis treatment in the previous 3 months

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
Verum Cefaly® Abortive Program deviceThe Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.	Device	Verum
Sham Cefaly® Abortive Program deviceThe Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.	Device	Sham

Primary outcome

Pain Freedom at 2 Hours
Time frame: 2 hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
Time frame: 2 hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.

5 secondary outcomes

Pain Relief at 2 Hours
Time frame: 2 hours
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
Time frame: 2 hours
Use of Rescue Medication Between 2 and 24 Hours
Time frame: 2-24 hours
Sustained Pain Freedom at 24 Hours
Time frame: 24 hours
Sustained Pain Relief at 24 Hours
Time frame: 2-24 hours

Results and safety

Results posted to the registry on 1 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Verum	299	259
Sham	308	279

Primary outcome: Pain Freedom at 2 Hours

Time frame: 2 hours. Count of participants. Unit: Participants

Measure	Verum n = 259	Sham n = 279
Value	66	51

Primary outcome: Most Bothersome Migraine-associated Symptom Freedom at 2 Hours

Time frame: 2 hours. Count of participants. Unit: Participants

Measure	Verum n = 259	Sham n = 279
Value	146	118

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The data was collected during the 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
Verum	0 of 298 (0%)	22 of 259 (8.5%)	0 of 298
Sham	1 of 303 (0.3%)	8 of 279 (2.9%)	0 of 303

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42231198Johnson MAL, Panza G, Kuruvilla DE. Migraine phases and treatment response: a post hoc analysis of participants with migraine with aura from the TEAM study. BMC Neurol. 2026 Jun 3. doi: 10.1186/s12883-026-05028-8. Online ahead of print.
Derived from this study: PubMed 35332216Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.
Individual participant dataSharing planned: No

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
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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.

Deena Kuruvilla, M.D. principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A study testing Verum Cefaly® Abortive Program device in people with Migraine, run by Cefaly Technology at 10 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 6 inclusion and 14 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 1 Jul 2019). 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 Freedom at 2 Hours (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 NCT03465904, 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 11 Dec 2024.