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Occipital Transcutaneous Stimulation in Chronic Migraine (OSCRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307071
Recruitment Status : Unknown
Verified May 2015 by Jean Schoenen, University of Liege.
Recruitment status was:  Recruiting
First Posted : December 3, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : November 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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.




Primary Outcome Measures :
  1. Monthly frequency of migraine days [ Time Frame: 2 months treatment ]

Secondary Outcome Measures :
  1. Monthly frequency of headache days [ Time Frame: 2 months ]
  2. Monthly frequency of total headache days [ Time Frame: 2 months ]
  3. Cumulative monthly headache hours [ Time Frame: 2 months ]
  4. Monthly acute drug intake [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • other diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307071


Contacts
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Contact: Anna Cosseddu, MD +3242256925 cossedduanna@gmail.com

Locations
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Belgium
CHR Citadelle Recruiting
Liege, Belgium, 4000
Contact: Anna Cosseddu, MD    +3242256925    cossedduanna@gmail.com   
Principal Investigator: Delphine Magis, MD         
Principal Investigator: Jean Schoenen, MD         
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Jean Schoenen, MD, PhD University of Liège
Principal Investigator: Delphine Magis, MD, PhD University of Liège

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Responsible Party: Jean Schoenen, Honorary Full Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02307071    
Other Study ID Numbers: OTSCM
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases