NCT00205894

Occipital Nerve Stimulation to Treat Chronic Headaches

Multicenter Feasibility Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Headache Disorders

Interventions

Type	Name	Description
DEVICE	bion microstimulator

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-10-01
• Completion: 2007-09-01
• First posted: 2005-09-21
• Last updated: 2008-09-05

Locations

2 sites across 1 country: United States