Occipital Nerve Stimulation to Treat Chronic Headaches
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|ClinicalTrials.gov Identifier: NCT00205894|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Headache Disorders||Device: bion microstimulator||Phase 1 Phase 2|
Chronic migraine and chronic cluster headaches are among the most disabling medical illnesses, inflicting severe functional impairment. These headache subtypes are particularly resistant to current treatment modalities, with the majority of chronic migraine patients continuing to experience frequent or near-daily headaches despite aggressive, multidisciplinary, and multimodal therapy. The refractory nature of these illnesses and the level of devastation they inflict on the lives of their victims has motivated the pursuit of novel treatment approaches.
Direct stimulation of the greater occipital nerve has been shown to alleviate the symptoms of chronic migraine and chronic cluster headaches in a small number of patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||September 2007|
- The primary safety measure is the incidence of major complications, defined as device or procedure related major adverse events that require medical and surgical intervention.
- The primary efficacy measure is a significant reduction in the frequency, severity or duration of the headaches from the preoperative to the three-month follow-up period.
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): NCT00205894
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Michigan|
|Michigan Head Pain & Neurological Institute|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||David Dodick, MD||Mayo Clinic|