Occipital Transcutaneous Stimulation in Chronic Migraine

Chronic Migraine Clinical Trial

— OSCRO  

Official title:

Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02307071
• Other study ID #: OTSCM
• Status: Recruiting
• Phase: Phase 4
• First received: December 1, 2014
• Last updated: May 27, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: University Hospital of Liege
• Contact: Anna Cosseddu, MD
• Phone: +3242256925
• Email: cossedduanna[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• other diseases

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• Cefaly Kit Arnold
Occipital neurostimulation can have a therapeutic effect in chronic migraine treatment, thus representing a possible therapeutic option in patients that do not respond to any medication.

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly frequency of migraine days		2 months treatment	No
Secondary	Monthly frequency of headache days		2 months	No
Secondary	Monthly frequency of total headache days		2 months	No
Secondary	Cumulative monthly headache hours		2 months	No
Secondary	Monthly acute drug intake		2 months	No