Occipital Transcutaneous Stimulation in Chronic Migraine

Phase 4

• Conditions: Chronic Migraine

• Registration Number: NCT02307071
• Lead Sponsor: University of Liege

Brief Summary

This study evaluates the effect in chronic migraine patients of daily 20 minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.

Detailed Description

Chronic migraine is a disabling neurological condition affecting 0.5-2% of the population.

CM is difficult to treat and preventive treatment options are limited. Due to the inefficiency of available and the lack of new preventive anti-migraine drug, neurostimulation methods have raised great interest in recent years.

The ONSTIM study showed a reduction in headache frequency in 39% of patients treated with active ONS during 12 weeks, compared to no improvement in the "non-effectively" stimulated or medically treated groups.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria

• other diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Monthly frequency of migraine days	2 months treatment

Secondary Outcome Measures

Name	Time	Method
Monthly frequency of headache days	2 months
Monthly acute drug intake	2 months
Monthly frequency of total headache days	2 months
Cumulative monthly headache hours	2 months

Trial Locations

Locations (1)

CHR Citadelle; 🇧🇪 Liege, Belgium