NCT02590939: ACME

Acute Treatment of Migraine With e-TNS

Completed NA Results posted Last updated 6 June 2018

What this trial tests

NA trial testing CEFALY Active in Migraine in 106 participants. Completed in 31 March 2017.

Timeline

1 February 2016

Primary endpoint
31 March 2017

31 March 2017

Quick facts

Lead sponsor	Cefaly Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	106
Start date	1 February 2016
Primary completion	31 March 2017
Estimated completion	31 March 2017
Sites	3 locations across United States

Drugs / interventions tested

• CEFALY Active
• CEFALY Placebo

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

Cefaly Technology

Who can join

Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score 1-hour Primary · 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

Group	Value	95% CI
Active Device	-59	± 35
Sham Device	-30	± 31

Pain Score 1-hour Primary · 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

Group	Value	95% CI
Active Device	-3.46	± 2.32
Sham Device	-1.78	± 1.89

Rescue Medication 2 Hours Secondary · 2 hours

Number of patients not having required rescue medication at 2 hours

Group	Value	95% CI
Active Device	3
Sham Device	2
Active Device	44
Sham Device	50
Active Device	5
Sham Device	2

Pain Score 2 Hours Secondary · 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)

Group	Value	95% CI
Active Device	-50	± 36
Sham Device	-32	± 37

Rescue Medication 24 Hours Secondary · 24 hours

Number of patients not having required rescue medication within 24 hours

Group	Value	95% CI
Active Device	18
Sham Device	21
Active Device	27
Sham Device	30
Active Device	7
Sham Device	3

Pain Score 24 Hours Secondary · 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)

Group	Value	95% CI
Active Device	-57	± 37
Sham Device	-40	± 40

Pain Score 2 Hours Secondary · 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)

Group	Value	95% CI
Active Device	-2.87	± 2.24
Sham Device	-1.85	± 1.96

Pain Score 24 Hours Secondary · 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)

Group	Value	95% CI
Active Device	-3.46	± 2.65
Sham Device	-2.38	± 2.27

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours following the beginning of the treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Device

Serious: 0/52 (0%)

Deaths: 0/52

Sham Device

Serious: 0/54 (0%)

Deaths: 0/54

Other adverse events (1 terms — click to expand)

Reaction	System	Active Device	Sham Device
Nausea	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02590939 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial.
   Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, et al · · 2019 · cited 93× · PMID 30449151 · DOI 10.1177/0333102418811573
2. An update on migraine: current understanding and future directions.
   Puledda F, Messina R, Goadsby PJ. · · 2017 · cited 78× · PMID 28321564 · DOI 10.1007/s00415-017-8434-y
3. Non-Pharmacological Approaches for Migraine.
   Puledda F, Shields K. · · 2018 · cited 66× · PMID 29616493 · DOI 10.1007/s13311-018-0623-6
4. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
5. Efficacy and safety of transcutaneous supraorbital nerve stimulation versus topiramate for migraine prevention: a non-inferiority randomized trial.
   Ye Y, Xie X, Huang H, Zhang H, et al · · 2026 · PMID 41981402 · DOI 10.1186/s10194-026-02367-2