Study Results
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View full resultsBasic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2006-02-28
2018-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
Active occipital nerve stimulation (stimulation on)
Precision
Implantable neurostimulator
Control
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Precision
Implantable neurostimulator
Interventions
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Precision
Implantable neurostimulator
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Lipton, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Mile High Research Center
Denver, Colorado, United States
The New England Center for Headache
Stamford, Connecticut, United States
Walton Rehabilitation Hospital
Augusta, Georgia, United States
Rush Pain Center
Chicago, Illinois, United States
Diamond Headache Clinic
Chicago, Illinois, United States
New England Regional Headache Center
Worcester, Massachusetts, United States
Headache Care Center
Springfield, Missouri, United States
Headache Specialists
Las Vegas, Nevada, United States
Albert Einstein College of Medicine - Montefiore Headache Unit
The Bronx, New York, United States
The Neurological Clinic
Portland, Oregon, United States
Thomas Jefferson University - Jefferson Headache
Philadelphia, Pennsylvania, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
Research Center
Fort Worth, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Swedish Pain & Headache Center
Seattle, Washington, United States
Countries
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Other Identifiers
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EI0105
Identifier Type: -
Identifier Source: org_study_id
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