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

NCT ID: NCT02342743

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2017-04-11

Brief Summary

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.

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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active

Daily trigeminal nerve stimulation session of 20 minutes with CEFALY

Group Type: EXPERIMENTAL

CEFALY

Intervention Type: DEVICE

Interventions

CEFALY

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cefaly Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marius Birlea, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Colorado Anschutz Medical Campus

Pierre Rigaux

Role: STUDY_DIRECTOR

Cefaly Technology

Locations

University of Colorado Anschutz Medical Campus - Department of Neurology

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

50207

Identifier Type: -

Identifier Source: org_study_id