Treatment for Migraines With an Implantable Device
This trial is active, not recruiting.
|Sponsor||Boston Scientific Corporation|
|Start date||February 2006|
|End date||April 2009|
|Trial size||179 participants|
|Trial identifier||NCT00286078, EI0105|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Denver, CO||Mile High Research Center||no longer recruiting|
|Stamford, CT||The New England Center for Headache||no longer recruiting|
|Augusta, GA||Walton Rehabilitation Hospital||no longer recruiting|
|Chicago, IL||Diamond Headache Clinic||no longer recruiting|
|Chicago, IL||Rush Pain Center||no longer recruiting|
|Springfield, MO||Headache Care Center||no longer recruiting|
|Las Vegas, NV||Headache Specialists||no longer recruiting|
|Bronx, NY||Albert Einstein College of Medicine - Montefiore Headache Unit||no longer recruiting|
|Portland, OR||The Neurological Clinic||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson University - Jefferson Headache||no longer recruiting|
|Nashville, TN||Nashville Neuroscience Group||no longer recruiting|
|Fort Worth, TX||Research Center||no longer recruiting|
|Salt Lake City, UT||Lifetree Clinical Research||no longer recruiting|
|Seattle, WA||Swedish Pain & Headache Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Migraine Frequency at 12 weeks
time frame: 12 weeks
Frequency of Adverse Event.
time frame: 26 weeks
Male or female participants at least 18 years old.
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. Exclusion: - 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.
|Official title||Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine|
|Principal investigator||Richard Lipton, MD|
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