OSCRO: Occipital Transcutaneous Stimulation in Chronic Migraine

Sponsor

University of Liege (Other)

Overall Status

Unknown status

CT.gov ID

NCT02307071

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Migraine	Device: Cefaly Kit Arnold	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cefaly Kit Arnold Occipital transcranial stimulation is implemented in occipital region at 16 mA of intensity, for 20 minutes, everyday for 3 months, in 20 chronic migraine patients.	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.

Arm

Intervention/Treatment

Experimental: Cefaly Kit Arnold

Occipital transcranial stimulation is implemented in occipital region at 16 mA of intensity, for 20 minutes, everyday for 3 months, in 20 chronic migraine patients.

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.

Outcome Measures

Primary Outcome Measures

Monthly frequency of migraine days [2 months treatment]

Secondary Outcome Measures

Monthly frequency of headache days [2 months]
Monthly frequency of total headache days [2 months]
Cumulative monthly headache hours [2 months]
Monthly acute drug intake [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

other diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR Citadelle	Liege		Belgium	4000

Sponsors and Collaborators

University of Liege

Investigators

Principal Investigator: Jean Schoenen, MD, PhD, University of Liege
Principal Investigator: Delphine Magis, MD, PhD, University of Liege

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean Schoenen, Honorary Full Professor, University of Liege

ClinicalTrials.gov Identifier:

NCT02307071

Other Study ID Numbers:

OTSCM

First Posted:

Dec 3, 2014

Last Update Posted:

May 28, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Migraine Disorders

Study Results

No Results Posted as of May 28, 2015