Acute Treatment of Migraine With e-TNS (ACME)
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ClinicalTrials.gov Identifier: NCT02590939 |
Recruitment Status :
Completed
First Posted : October 29, 2015
Results First Posted : April 9, 2018
Last Update Posted : June 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Device: CEFALY Active Device: CEFALY Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 106 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device |
Actual Study Start Date : | February 1, 2016 |
Actual Primary Completion Date : | March 31, 2017 |
Actual Study Completion Date : | March 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Active device
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
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Device: CEFALY Active
Active external trigeminal nerve stimulation |
Sham Comparator: Sham device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
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Device: CEFALY Placebo
Placebo external trigeminal nerve stimulation |
- 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
- Rescue Medication 2 Hours [ Time Frame: 2 hours ]Number of patients not having required rescue medication at 2 hours
- Pain Score 2 Hours [ Time Frame: 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 [ Time Frame: 24 hours ]Number of patients not having required rescue medication within 24 hours
- Pain Score 24 Hours [ Time Frame: 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)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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®

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590939
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06510 | |
United States, Kansas | |
Rowe Neurology Institute | |
Lenexa, Kansas, United States, 66214-9836 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10019 |
Principal Investigator: | Denise Chou, M.D. | Columbia University |
Documents provided by Cefaly Technology:
Responsible Party: | Cefaly Technology |
ClinicalTrials.gov Identifier: | NCT02590939 |
Other Study ID Numbers: |
50213 |
First Posted: | October 29, 2015 Key Record Dates |
Results First Posted: | April 9, 2018 |
Last Update Posted: | June 6, 2018 |
Last Verified: | May 2018 |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |