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Occipital Transcutaneous Stimulation in Chronic Migraine

Phase 4
Conditions
Chronic Migraine
Interventions
Device: Cefaly Kit Arnold
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.

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
Arm && Interventions
GroupInterventionDescription
Cefaly Kit ArnoldCefaly Kit ArnoldOccipital transcranial stimulation is implemented in occipital region at 16 mA of intensity, for 20 minutes, everyday for 3 months, in 20 chronic migraine patients.
Primary Outcome Measures
NameTimeMethod
Monthly frequency of migraine days2 months treatment
Secondary Outcome Measures
NameTimeMethod
Monthly frequency of headache days2 months
Monthly acute drug intake2 months
Monthly frequency of total headache days2 months
Cumulative monthly headache hours2 months

Trial Locations

Locations (1)

CHR Citadelle

🇧🇪

Liege, Belgium

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