Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
OPTIMISE
2 other identifiers
interventional
28
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedStudy Start
First participant enrolled
April 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2017
CompletedResults Posted
Study results publicly available
November 2, 2018
CompletedNovember 13, 2020
November 1, 2020
2.6 years
January 23, 2013
May 29, 2018
November 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
from Baseline to 6 months post-randomization
Study Arms (2)
Treatment
EXPERIMENTALThe treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Control
ACTIVE COMPARATORThe 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
Interventions
Electrical stimulation of the greater occipital nerve
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, 91355, United States
University of Illinois at Chicago (Implanting Physician)
Chicago, Illinois, 60612, United States
Diamond Headache Clinic (Headache Physician)
Chicago, Illinois, 60642, United States
Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
Shreveport, Louisiana, 71105, United States
Henry Ford Hospital (Headache Physician)
Detroit, Michigan, 48202, United States
Henry Ford Medical Group (Implanting Physician)
West Bloomfield, Michigan, 48322, United States
Mercy Pain Management -Surgery Center (Implanting Physician)
Springfield, Missouri, 65804, United States
Clinvest Research, LLC (Headache Physician)
Springfield, Missouri, 65807, United States
NYU Medical Center (Implanting Physician)
New York, New York, 10016, United States
Montefiore Headache Center (Headache Physician)
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed. Statistical analysis was not performed as the sample size was too small to draw any statistically relevant conclusions.
Results Point of Contact
- Title
- Director, Clinical Sciences and Scientific Communication
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lipton, MD
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2013
First Posted
January 25, 2013
Study Start
April 10, 2013
Primary Completion
December 1, 2015
Study Completion
January 19, 2017
Last Updated
November 13, 2020
Results First Posted
November 2, 2018
Record last verified: 2020-11