Occipital Nerve Stimulation to Treat Chronic Headaches

Completed · Phase 1/Phase 2

Conditions studied: Headache Disorders

In brief

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.

Key facts

Study ID

NCT00205894

Run by

Boston Scientific Corporation

People needed

20

Starts

2004-01-01

Expected to finish

2007-09-01

Last updated by the study team

2008-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
• Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade currently in effect;
• Have had a previous surgery in the intended implant area;
• Have Arnold-Chiari malformation;
• Have participated within the last 30 days or plan to participate within the next 4 months in a device or drug trial;
• Be pregnant or planning on becoming pregnant during the study period;
• Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy; and
• Currently require, or be likely to require, MRI or diathermy.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Michigan Head Pain & Neurological Institute — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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