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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Mayo Clinic
Scottsdale, Arizona, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
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.
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