Clinical Studies: Proven Migraine Relief with Cefaly

Clinical Studies

Cefaly is an evidence-based, non-invasive neuromodulation treatment for migraine.

20+ years of research

Tested in more than 12 clinical trials and published in 18 peer-reviewed publications

Three pivotal, prospective, multicenter, sham-controlled randomized controlled trials

FDA cleared for preventive and acute migraine treatment

Cefaly significantly reduces migraine pain.

Results from the Acute migraine therapy with external trigeminal neurostimulation (ACME) study:

79%

of patients saw a significant reduction in headache pain after one hour of Cefaly Acute treatment.

63%

of patients said one hour of Acute treatment decreased their pain by half — or more.

Acute Migraine Therapy with External Trigeminal Neurostimulation (ACME)

Background: The ACME trial was a multicenter, double-blind, randomized, sham-controlled study evaluating the safety and efficacy of external trigeminal nerve stimulation (e-TNS) for acute migraine treatment. 

Conducted across three U.S. headache centers between February 2016 and March 2017, the study enrolled 106 adults (aged 18–65) with migraine with or without aura, who were actively experiencing an attack of at least 3 hours’ duration with stable pain for 1 hour. Participants were randomized 1:1 to receive either verum or sham e-TNS using the Cefaly device for a single 1-hour session. 

Clinical Summary: The ACME trial provides Class II evidence supporting e-TNS as a safe, non-invasive, and effective acute migraine treatment. It demonstrated significant pain relief at multiple time points, high patient tolerability, and no serious side effects, making it a promising alternative to pharmacologic treatment of migraine abortive therapies, particularly for patients with medication contraindications or intolerance.

Read the ACME study

Results from the Acute migraine therapy with external trigeminal neurostimulation (ACME) study:

79%

of patients saw a significant reduction in headache pain after one hour of Cefaly Acute treatment.

63%

of patients said one hour of Acute treatment decreased their pain by half — or more.

Cefaly relieves migraine-associated nausea, vomiting, and light and sound sensitivity.

Results from the Trial of e-TNS for the Acute Treatment of Migraine (TEAM) study:

56.4%

of patients said Cefaly resolved their most bothersome migraine symptom (MBS) after 2 hours of treatment.

67.3%

of patients who identified nausea as their MBS reported that nausea was resolved.

42.5%

of patients said Cefaly resolved all migraine symptoms after 2 hours of Acute treatment.

Phase 3 Randomized, Double-Blind, Sham-Controlled Trial of E-TNS For the Acute Treatment of Migraine (TEAM)

Background: The TEAM study was a multicenter, randomized, double-blind, sham-controlled Phase 3 trial evaluating the efficacy and safety of a 2-hour e-TNS treatment for acute migraine.

The study was conducted in 2022 across 10 U.S. sites and included an intention-to-treat (ITT) and per-protocol (PP) analysis. A total of 538 patients aged 18–65 with 2–8 monthly migraine days were randomized 1:1 to receive a single 2-hour session of either verum or sham stimulation during one qualifying migraine attack. All participants had at least one year of migraine history and were trained to self-administer the e-TNS therapy and complete headache diaries.

Clinical Summary: Non-pain symptoms have a significant impact on migraine patients’ quality of life. The TEAM trial provides robust evidence that 2-hour e-TNS therapy is a safe, effective, and practical acute treatment for episodic migraine — both pain and MBS — in a real-world, at-home context. This was the largest study to date examining e-TNS for migraine, and was followed up by a post hoc analysis examining each MBS type.

Read the TEAM study

Read a post hoc analysis of migraine-associated symptoms from the TEAM study

Results from the Trial of e-TNS for the Acute Treatment of Migraine (TEAM) study:

56.4%

of patients said Cefaly resolved their most bothersome migraine symptom (MBS) after 2 hours of treatment.

67.3%

of patients who identified nausea as their MBS reported that nausea was resolved.

42.5%

of patients said Cefaly resolved all migraine symptoms after 2 hours of Acute treatment.

Cefaly decreases migraine days and can also reduce medication intake.

Results from the Medication Prevention With a Supraorbital Transcutaneous Stimulator (PREMICE) study:

32.7%

decrease in headache days among patients after 3 months of compliant Prevent treatment

74.4%

decrease in acute migraine medication intake among patients who responded to Prevent treatment with Cefaly (after 3 months)

36.6%

decrease in acute migraine medication intake among patients after 3 months of Prevent treatment with Cefaly.

Medication Prevention with A Supraorbital Transcutaneous Stimulator (PREMICE)

Background: The PREMICE study was a multicenter, double-blind, randomized, sham-controlled trial to assess the efficacy and safety of a supraorbital transcutaneous stimulator (Cefaly) for migraine prevention. 

The study was conducted between September 2009 and September 2011 across five tertiary headache centers in Belgium. Eligible participants were adults aged 18 to 65 years with at least two migraine attacks per month and a diagnosis of migraine with or without aura per ICHD-II criteria. A total of 67 patients were randomized 1:1 into either the verum (active) or sham (placebo) stimulation group following a one-month baseline run-in period. Daily neurostimulation was self-administered for 20 minutes over a three-month period using the Cefaly device. 

Clinical Summary: The PREMICE trial offers meaningful evidence that daily supraorbital neurostimulation using the Cefaly device is a safe, well-tolerated, and effective non-pharmacological treatment for the prevention of episodic migraine. Its efficacy is comparable to oral preventives, and its excellent tolerability makes it an attractive first-line or adjunctive option in patients seeking alternatives to medication-based prophylaxis.

Read the PREMICE study

Results from the Medication Prevention With a Supraorbital Transcutaneous Stimulator (PREMICE) study:

32.7%

decrease in headache days among patients after 3 months of compliant Prevent treatment

74.4%

decrease in acute migraine medication intake among patients who responded to Prevent treatment with Cefaly (after 3 months)

36.6%

decrease in acute migraine medication intake among patients after 3 months of Prevent treatment with Cefaly.

Safety & Tolerability

Multiple clinical studies have demonstrated that there are no serious adverse effects associated with Cefaly treatment.

Adverse effects are minor, fully reversible upon cessation, and superior to the tolerability profile of most migraine pharmaceuticals.

Cefaly’s safety and tolerability profile is superior to many prescription medications for migraine.

Indications

Acute treatment of migraine (with or without aura) in patients 18+.

Preventive treatment of migraine in patients 18+.

Ideal for migraine patients who:

Prefer non-pharmaceutical migraine treatment options
Don’t respond to pharmaceutical treatments
Cannot tolerate migraine medication
Are seeking clinically proven alternatives to pharmaceuticals
Are at risk for drug-drug interactions because of co-existing medical conditions
Have limited access to outpatient treatment procedures

Contraindications

Do not use if you have:

Metallic or electronic implants in the head

A cardiac pacemaker

An implanted/wearable defibrillator

Not for use on pain of unknown origins

Safety & Tolerability

Multiple clinical studies have demonstrated that there are no serious adverse effects associated with Cefaly treatment.

Adverse effects are minor and fully reversible upon cessation of device use.

Cefaly’s safety and tolerability profile is superior to that of many prescription medications for migraine.

Side Effects

Sleepiness, headache after a session (common); forehead skin redness, nausea (uncommon); forehead skin allergy (rare).

Report an Adverse Event

To report suspected adverse reactions, contact Cefaly’s Regulatory Affairs team at 1-844-475-7100 or regulatory@cefaly.com.