Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE (OPTIMISE)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Migraine Disorders	Device: Occipital nerve stimulator	Not Applicable

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Study Start Date :	January 2013
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	June 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment Group A; The treatment device is an occipital nerve stimulator, specifically the BSC Precision™ ONS System	Device: Occipital nerve stimulator; Electrical stimulation of the greater occipital nerve; Other Name: Boston Scientific Precision System
Active Comparator: Treatment Group B; The treatment device is on occipital nerve stimulator, specifically the BSC Precision™ ONS System	Device: Occipital nerve stimulator; Electrical stimulation of the greater occipital nerve; Other Name: Boston Scientific Precision System

Outcome Measures

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Primary Outcome Measures :

1. 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:

   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 will be 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. The 6 months post-randomization number will be 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.

Secondary Outcome Measures :

1. Moderate-to-severe headache frequency response [ Time Frame: 6 months post-randomization ]
   A responder will be defined as any subject achieving ≥50% reduction in the total count of moderate-to-severe headache days from the first 30 calendar days of eDiary entries to the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
2. Conversion to <15 moderate-to-severe headache days per month [ Time Frame: 6 months post-randomization ]
   A conversion subject will be defined as any subject with <15 total count of moderate-to-severe headache days during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
3. Change in average number of moderate-to-severe headache hours per day [ Time Frame: from Baseline to 6 months post-randomization ]
   The number of moderate-to-severe headache hours for a given day will be defined as the number of hours in the corresponding eDiary entry that the subject spent with a headache with a peak intensity of moderate or severe. A calendar day with a peak intensity of mild will have 0 moderate-to-severe headache hours.
4. Change in daily headache intensity [ Time Frame: from Baseline to 6 months post-randomization ]
   Daily headache intensity will be calculated based on the Average Intensity question, collected using the eDiary, starting at the beginning of the 30-day Baseline eDiary period and ending at 6 months post-randomization.
5. Headache intensity response (30%) [ Time Frame: 6 months post-randomization ]
   For this endpoint, a responder will be defined as any subject achieving ≥30% reduction in daily headache intensity from the first 30 calendar days of eDiary entries to the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit.
6. Change in headache impact [ Time Frame: from Baseline to 6 months post-randomization ]
   Headache impact will be based on headache impact test (HIT-6) questionnaire, completed by the subject at the Baseline and 6-Month Visits.
7. Change in migraine-specific quality of life [ Time Frame: from Baseline to 6 months post-randomization ]
   Migraine-specific quality-of-life (MSQ) will be based on MSQ v2.1 questionnaire completed by the subject at the Baseline and 6-Month Visits.
8. Subject satisfaction with treatment [ Time Frame: 6 months post-randomization ]
   Subject satisfaction with treatment will be based on a modified treatment satisfaction questionnaire (TSQM-9) completed by the subject at the Baseline and 6-Month Visits. Subject satisfaction with treatment will be calculated as the total TSQM-9 score across all the domains of the questionnaire.
9. Rate of adverse events (AEs) [ Time Frame: 6 months post-randomization ]
   An adverse event is any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, United States, 91355

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Richard Lipton, MD	Albert Einstein College of Medicine, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01775735 History of Changes
Other Study ID Numbers:	G120051; CDM00046436 ( Other Identifier: BSC protocol number )
First Posted:	January 25, 2013
Last Update Posted:	July 4, 2016
Last Verified:	July 2016

Keywords provided by Boston Scientific Corporation:

headache; pain; chronic

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders	Brain Diseases; Central Nervous System Diseases; Nervous System Diseases