Occipital Nerve Stimulation to Treat Chronic Headaches
The purpose of this study is to evaluate the safety and efficacy of a implantable device, called the bion(R), in the treatment of chronic headache. The bion microstimulator is placed underneath the skin next to the greater occipital nerve. The bion microstimulator then stimulates the nerve by generating small amounts of electrical current.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches|
- 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.
|Study Start Date:||January 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
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.
|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|