The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
179
Implantable neurostimulator
Mile High Research Center
Denver, Colorado, United States
The New England Center for Headache
Stamford, Connecticut, United States
Migraine Frequency at 12 Weeks
Change from baseline in migraine days/month at 12 weeks
Time frame: Baseline and 12 weeks
Frequency of Adverse Event
Cumulative frequency of adverse events from randomization to 26 weeks
Time frame: 26 weeks
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