Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

Completed · Phase 1

Conditions studied: Chronic Migraine Headache

In brief

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.

Key facts

Study ID

NCT00200109

Run by

MedtronicNeuro

People needed

110

Starts

2004-05-01

Expected to finish

2011-05-01

Last updated by the study team

2011-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• previous surgical procedures to disrupt the nerves of the neck relating to the headache
• subjects who may require MRI or Diathermy

Where it is running

• Contact Medtronic for Exact Location — Scottsdale, Arizona, United States
• Contact Medtronic for Exact Locations — Oceanside, California, United States
• Contact Medtronic for Exact Locations — Denver, Colorado, United States
• Contact Medtronic for Exact Locations — Ann Arbor, Michigan, United States
• Contact Medtronic for Exact Locations — Detroit, Michigan, United States
• Contact Medtronic for Exact Locations — Oklahoma City, Oklahoma, United States
• Contact Medtronic for Exact Locations — Philadelphia, Pennsylvania, United States
• Contact Medtronic for Exact Location — Calgary, Alberta, Canada
• Contact Medtronic for Exact Location — London, United Kingdom

Full record on ClinicalTrials.gov

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