Status:
COMPLETED
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Migraine Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 feasibi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
- compliance with daily questionnaire
- headache that has not responded to at least two classes of headache medications
- stable headache medication regimen
Exclusion
- previous surgical procedures to disrupt the nerves of the neck relating to the headache
- subjects who may require MRI or Diathermy
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00200109
Start Date
May 1 2004
End Date
May 1 2011
Last Update
October 12 2011
Active Locations (9)
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1
Contact Medtronic for Exact Location
Scottsdale, Arizona, United States, 85054
2
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Oceanside, California, United States, 92024
3
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Denver, Colorado, United States, 80045
4
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Ann Arbor, Michigan, United States, 48104