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ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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Scottsdale, Arizona, United States
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Oceanside, California, United States
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Denver, Colorado, United States
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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
Start Date
May 1, 2004
Primary Completion Date
June 1, 2008
Completion Date
May 1, 2011
Last Updated
October 12, 2011
110
ACTUAL participants
Occipital Nerve Stimulation
DEVICE
Lead Sponsor
MedtronicNeuro
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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