Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE

Conditions
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Migraine Disorders

Intervention / Treatment
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* Device: Occipital nerve stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization | Device: Occipital nerve stimulator<br>* Electrical stimulation of the greater occipital nerve<br>* Other names: Boston Scientific Precision System;|
| Active Comparator: Control<br>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 | Device: Occipital nerve stimulator<br>* Electrical stimulation of the greater occipital nerve<br>* Other names: Boston Scientific Precision System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. | from Baseline to 6 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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headache, pain, chronic