Treatment for Migraines With an Implantable Device

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Be diagnosed with multiple migraines per month of moderate to severe intensity;
Be refractory to medication;
Be an appropriate candidate for the surgical procedures required for this study;
Be willing and able to comply with all study related procedures;
Be capable of reading and understanding patient information materials and giving written informed consent.

Key

Exclusion Criteria

Have onset of migraine after age 50;
Have a significant psychiatric disorder;
Have previously been treated with occipital nerve stimulation;
Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;
Have a condition currently requiring or likely to require the use of MRI or diathermy;
Have an active implantable device;
Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.

Arm && Interventions

Group	Intervention	Description
Treatment	Precision	Active occipital nerve stimulation (stimulation on)
Control	Precision	Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Event	26 weeks	Cumulative frequency of adverse events from randomization to 26 weeks
Migraine Frequency at 12 Weeks	Baseline and 12 weeks	Change from baseline in migraine days/month at 12 weeks

Secondary Outcome Measures

Name	Time	Method

Locations (15): New England Regional Headache Center
🇺🇸
Worcester, Massachusetts, United States
Thomas Jefferson University - Jefferson Headache
🇺🇸
Philadelphia, Pennsylvania, United States
Walton Rehabilitation Hospital
🇺🇸
Augusta, Georgia, United States
Rush Pain Center
🇺🇸
Chicago, Illinois, United States
Diamond Headache Clinic
🇺🇸
Chicago, Illinois, United States
Headache Care Center
🇺🇸
Springfield, Missouri, United States
Albert Einstein College of Medicine - Montefiore Headache Unit
🇺🇸
Bronx, New York, United States
Research Center
🇺🇸
Fort Worth, Texas, United States
The New England Center for Headache
🇺🇸
Stamford, Connecticut, United States
Mile High Research Center
🇺🇸
Denver, Colorado, United States
Nashville Neuroscience Group
🇺🇸
Nashville, Tennessee, United States
Lifetree Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Swedish Pain & Headache Center
🇺🇸
Seattle, Washington, United States
Headache Specialists
🇺🇸
Las Vegas, Nevada, United States
The Neurological Clinic
🇺🇸
Portland, Oregon, United States