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

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Be diagnosed with chronic migraine, probable chronic migraine, and/or chronic cluster headache according to the 2004 IHS Classification Criteria (2nd ed.) or be diagnosed with migraine with or without aura

• Be 18 years of age or older

• Be willing and able to follow all study-related procedures during the course of the study;

• Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventative classes.

Locations
United States
Arizona
Mayo Clinic
Scottsdale
Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor
Time Frame
Start Date: January 2004
Completion Date: September 2007
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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