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Acute Treatment of Migraine Using the CEFALY Device

Primary Purpose

Migraine

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CEFALY

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.

Exclusion Criteria:

Pregnant women
Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head 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 headaches
Patients taking opioid medications
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 while the neurostimulation has already started).
Implanted metal or electrical devices in the head
Cardiac pacemaker or implanted or wearable defibrillator

Sites / Locations

Columbia University Headache Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

60 minutes of CEFALY stimulation as acute treatment of an on-going attack

Outcomes

Primary Outcome Measures

Change of pain intensity at 1 hour (VAS score)

Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

Secondary Outcome Measures

Change of pain intensity at 2 hours (VAS score)

Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

Patients with no need of medication at 2 hours

Percentage of patients not having required rescue medication after 2 hours

Patients with no need of medication at 24 hours

Percentage of patients not having required rescue medication after 2 hours

Full Information

NCT ID

NCT02411513

First Posted

March 31, 2015

Last Updated

December 3, 2015

Sponsor

Cefaly Technology

1. Study Identification

Unique Protocol Identification Number

NCT02411513

Brief Title

Acute Treatment of Migraine Using the CEFALY Device

Official Title

Open-trial on the Acute Treatment of Migraine Using the CEFALY Device

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cefaly Technology

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

60 minutes of CEFALY stimulation as acute treatment of an on-going attack

Intervention Type

Device

Intervention Name(s)

CEFALY

Primary Outcome Measure Information:

Title

Change of pain intensity at 1 hour (VAS score)

Description

Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Change of pain intensity at 2 hours (VAS score)

Description

Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11

Time Frame

2 hours

Title

Patients with no need of medication at 2 hours

Description

Percentage of patients not having required rescue medication after 2 hours

Time Frame

2 hours

Title

Patients with no need of medication at 24 hours

Description

Percentage of patients not having required rescue medication after 2 hours

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction) The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side. Exclusion Criteria: Pregnant women Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head 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 headaches Patients taking opioid medications 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 while the neurostimulation has already started). Implanted metal or electrical devices in the head Cardiac pacemaker or implanted or wearable defibrillator

Facility Information:

Facility Name

Columbia University Headache Center

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

12. IPD Sharing Statement

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Acute Treatment of Migraine Using the CEFALY Device

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