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Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.
Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).
Age
21 - 75 years
Sex
ALL
Healthy Volunteers
No
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, United States
University of Illinois at Chicago (Implanting Physician)
Chicago, Illinois, United States
Diamond Headache Clinic (Headache Physician)
Chicago, Illinois, United States
Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
Shreveport, Louisiana, United States
Henry Ford Hospital (Headache Physician)
Detroit, Michigan, United States
Henry Ford Medical Group (Implanting Physician)
West Bloomfield, Michigan, United States
Mercy Pain Management -Surgery Center (Implanting Physician)
Springfield, Missouri, United States
Clinvest Research, LLC (Headache Physician)
Springfield, Missouri, United States
NYU Medical Center (Implanting Physician)
New York, New York, United States
Montefiore Headache Center (Headache Physician)
The Bronx, New York, United States
Start Date
April 10, 2013
Primary Completion Date
December 1, 2015
Completion Date
January 19, 2017
Last Updated
November 13, 2020
28
ACTUAL participants
Occipital nerve stimulator
DEVICE
Lead Sponsor
Boston Scientific Corporation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05690737