Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE (OPTIMISE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01775735 |
Recruitment Status :
Terminated
First Posted : January 25, 2013
Results First Posted : November 2, 2018
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Disorders | Device: Occipital nerve stimulator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE |
Actual Study Start Date : | April 10, 2013 |
Actual Primary Completion Date : | December 1, 2015 |
Actual Study Completion Date : | January 19, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
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Device: Occipital nerve stimulator
Electrical stimulation of the greater occipital nerve
Other Name: Boston Scientific Precision System |
Active Comparator: Control
The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
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Device: Occipital nerve stimulator
Electrical stimulation of the greater occipital nerve
Other Name: Boston Scientific Precision System |
- Change in the Number of Moderate-to-severe Headache Days Per Month [ Time Frame: from Baseline to 6 months post-randomization ]
A moderate-to-severe headache day will be defined as any calendar day with:
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headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity
OR
- 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.
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
- Evidence of intractability
- Posterior-dominant head pain
- Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
- Onset of migraine before the age of 50
- If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test
Key Exclusion Criteria:
- Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
- Untreated panic disorder
- Untreated major depression evidenced by a PHQ-9 score >20
- Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
- Currently diagnosed with severe personality disorder
- A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
- Participating in another drug, device, or biologics trial within 3 months prior to Screening
- A terminal illness associated with survival <24 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775735
United States, California | |
Boston Scientific Clinical Research Information Toll Free Number | |
Valencia, California, United States, 91355 | |
United States, Illinois | |
University of Illinois at Chicago (Implanting Physician) | |
Chicago, Illinois, United States, 60612 | |
Diamond Headache Clinic (Headache Physician) | |
Chicago, Illinois, United States, 60642 | |
United States, Louisiana | |
Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician) | |
Shreveport, Louisiana, United States, 71105 | |
United States, Michigan | |
Henry Ford Hospital (Headache Physician) | |
Detroit, Michigan, United States, 48202 | |
Henry Ford Medical Group (Implanting Physician) | |
West Bloomfield, Michigan, United States, 48322 | |
United States, Missouri | |
Mercy Pain Management -Surgery Center (Implanting Physician) | |
Springfield, Missouri, United States, 65804 | |
Clinvest Research, LLC (Headache Physician) | |
Springfield, Missouri, United States, 65807 | |
United States, New York | |
Montefiore Headache Center (Headache Physician) | |
Bronx, New York, United States, 10461 | |
NYU Medical Center (Implanting Physician) | |
New York, New York, United States, 10016 |
Principal Investigator: | Richard Lipton, MD | Albert Einstein College of Medicine |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT01775735 |
Other Study ID Numbers: |
G120051 CDM00046436 ( Other Identifier: BSC protocol number ) |
First Posted: | January 25, 2013 Key Record Dates |
Results First Posted: | November 2, 2018 |
Last Update Posted: | November 13, 2020 |
Last Verified: | November 2020 |
headache pain chronic |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |