Occipital Transcutaneous Stimulation in Chronic Migraine (OSCRO)

May 27, 2015 updated by: Jean Schoenen, University of Liege

Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • CHR Citadelle
        • Contact:
        • Principal Investigator:
          • Delphine Magis, MD
        • Principal Investigator:
          • Jean Schoenen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • other diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monthly frequency of migraine days
Time Frame: 2 months treatment
2 months treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Monthly frequency of headache days
Time Frame: 2 months
2 months
Monthly frequency of total headache days
Time Frame: 2 months
2 months
Cumulative monthly headache hours
Time Frame: 2 months
2 months
Monthly acute drug intake
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTSCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Migraine

Clinical Trials on Cefaly Kit Arnold

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe