Clinical Trial: Occipital Nerve Stimulation to Treat Chronic Headaches

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Boston Scientific Corporation

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Scientific Corporation

Dates:
Date Received: September 13, 2005
Date Started: January 2004
Date Completion:
Last Updated: September 4, 2008
Last Verified: August 2008