Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
110
Each group had a different plan
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Scottsdale, Arizona, United States
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Oceanside, California, United States
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Denver, Colorado, United States
A primary endpoint is not identified for this feasibility study.
Time frame: No primary endpoint
Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.
Time frame: No secondary endpoint
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Calgary, Alberta, Canada
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London, United Kingdom