Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
NCT ID: NCT00200109
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
110 participants
INTERVENTIONAL
2004-05-31
2011-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Group 1
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Occipital Nerve Stimulation
Each group had a different plan
Group 2
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Occipital Nerve Stimulation
Each group had a different plan
Group 3
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Occipital Nerve Stimulation
Each group had a different plan
Group 4
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Occipital Nerve Stimulation
Each group had a different plan
Interventions
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Occipital Nerve Stimulation
Each group had a different plan
Eligibility Criteria
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Inclusion Criteria
* compliance with daily questionnaire
* headache that has not responded to at least two classes of headache medications
* stable headache medication regimen
Exclusion Criteria
* subjects who may require MRI or Diathermy
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Saper, M.D.
Role: PRINCIPAL_INVESTIGATOR
Michigan Head Pain and Neurological Institute, Ann Arbor, MI
Locations
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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
Countries
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References
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Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.
Other Identifiers
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1602
Identifier Type: -
Identifier Source: org_study_id