Chronic Migraine Headache Clinical Trial
Official title:
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)