Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

June 5, 2019 updated by: Cefaly Technology
The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus - Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a history of chronic migraine 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) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.

Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

Exclusion Criteria:

  1. Women: Pregnant, lactating or <6 months post partum
  2. For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
  3. For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
  4. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
  5. A Beck Depression Inventory score of >24 at baseline
  6. Psychiatric disorders that could have interfered with study participation
  7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
Device: CEFALY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Frequency of Headache Days
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period
Change From Baseline in Acute Medication Intake
Time Frame: End of baseline period and end of 12 weeks treatment period
Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frequency of Migraine Days
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period
Change in Frequency of Moderate/Severe Headache Days
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period
Change in Monthly Cumulative Headache Hours
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period
Change in Frequency of Headache Episodes
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of baseline period and end of 12 weeks treatment period
50% Responder Rate for Migraine Days
Time Frame: End of the 12 weeks treatment period
Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment.
End of the 12 weeks treatment period
Change in the Average Headache Intensity
Time Frame: End of baseline period and end of 12 weeks treatment period
Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain).
End of baseline period and end of 12 weeks treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cefaly Technology

Investigators

  • Principal Investigator: Marius Birlea, MD, Department of Neurology, University of Colorado Anschutz Medical Campus
  • Study Director: Pierre Rigaux, Cefaly Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2015

Primary Completion (Actual)

April 11, 2017

Study Completion (Actual)

April 11, 2017

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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