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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Electrical stimulation of the greater occipital nerve
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
Change in the Number of Moderate-to-severe Headache Days Per Month
A moderate-to-severe headache day will be defined as any calendar day with: 1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR 2. a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.
Time frame: from Baseline to 6 months post-randomization
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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