Status:
COMPLETED
Occipital Nerve Stimulation to Treat Chronic Headaches
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Headache Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 sk...
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 tr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00205894
Start Date
January 1 2004
End Date
September 1 2007
Last Update
September 5 2008
Active Locations (2)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104