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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02590939
Other study ID # 50213
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date March 31, 2017

Study information

Verified date May 2018
Source Cefaly Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 and after the treatment.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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®

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CEFALY Active
Active external trigeminal nerve stimulation
CEFALY Placebo
Placebo external trigeminal nerve stimulation

Locations

Country Name City State
United States Rowe Neurology Institute Lenexa Kansas
United States Yale University School of Medicine New Haven Connecticut
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Cefaly Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 hour
Secondary Rescue Medication 2 Hours Number of patients not having required rescue medication at 2 hours 2 hours
Secondary 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) 2 hours
Secondary Rescue Medication 24 Hours Number of patients not having required rescue medication within 24 hours 24 hours
Secondary 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) 24 hours
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