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Occipital Transcutaneous Stimulation in Chronic Migraine (OSCRO)

Primary Purpose

Chronic Migraine

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Cefaly Kit Arnold
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • other diseases

Sites / Locations

  • CHR CitadelleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cefaly Kit Arnold

Arm Description

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.

Outcomes

Primary Outcome Measures

Monthly frequency of migraine days

Secondary Outcome Measures

Monthly frequency of headache days
Monthly frequency of total headache days
Cumulative monthly headache hours
Monthly acute drug intake

Full Information

First Posted
December 1, 2014
Last Updated
May 27, 2015
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02307071
Brief Title
Occipital Transcutaneous Stimulation in Chronic Migraine
Acronym
OSCRO
Official Title
Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cefaly Kit Arnold
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cefaly Kit Arnold
Intervention Description
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.
Primary Outcome Measure Information:
Title
Monthly frequency of migraine days
Time Frame
2 months treatment
Secondary Outcome Measure Information:
Title
Monthly frequency of headache days
Time Frame
2 months
Title
Monthly frequency of total headache days
Time Frame
2 months
Title
Cumulative monthly headache hours
Time Frame
2 months
Title
Monthly acute drug intake
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse Exclusion Criteria: other diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Cosseddu, MD
Phone
+3242256925
Email
cossedduanna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, MD, PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Delphine Magis, MD, PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Cosseddu, MD
Phone
+3242256925
Email
cossedduanna@gmail.com
First Name & Middle Initial & Last Name & Degree
Delphine Magis, MD
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, MD

12. IPD Sharing Statement

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Occipital Transcutaneous Stimulation in Chronic Migraine

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