Acute Treatment of Migraine Using the CEFALY Device

NCT02411513 | Completed Phase 1

• 1 other identifier: 50208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Secondary Outcomes (3)

• Change of pain intensity at 2 hours (VAS score)

  2 hours

• Patients with no need of medication at 2 hours

  2 hours

• Patients with no need of medication at 24 hours

  24 hours

Study Arms (1)

Active

EXPERIMENTAL

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

Device: CEFALY

Interventions

CEFALY DEVICE

Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (1)

Columbia University Headache Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 8, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

US (1)