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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine||Device: Cefaly Kit Arnold||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Monthly frequency of migraine days [ Time Frame: 2 months treatment ]
- Monthly frequency of headache days [ Time Frame: 2 months ]
- Monthly frequency of total headache days [ Time Frame: 2 months ]
- Cumulative monthly headache hours [ Time Frame: 2 months ]
- Monthly acute drug intake [ Time Frame: 2 months ]
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
|Contact: Anna Cosseddu, MDfirstname.lastname@example.org|
|Liege, Belgium, 4000|
|Contact: Anna Cosseddu, MD +3242256925 email@example.com|
|Principal Investigator: Delphine Magis, MD|
|Principal Investigator: Jean Schoenen, MD|
|Principal Investigator:||Jean Schoenen, MD, PhD||University of Liege|
|Principal Investigator:||Delphine Magis, MD, PhD||University of Liege|