Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

Not Applicable

Terminated

• Conditions: Migraine Disorders
• Interventions: Device: Occipital nerve stimulator

• Registration Number: NCT01775735
• Lead Sponsor: Boston Scientific Corporation

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-25
• Study Start: 2013-04-10
• Primary Completion: 2015-12-01
• Study Completion: 2017-01-19
• Results First Submitted: 2018-05-29
• Results First Submitted QC: 2018-10-29
• Results First Posted: 2018-11-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Occipital nerve stimulator	The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Control	Occipital nerve stimulator	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

Primary Outcome Measures

Name	Time	Method
Change in the Number of Moderate-to-severe Headache Days Per Month	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 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.

Trial Locations

Locations (10)

Henry Ford Medical Group (Implanting Physician); 🇺🇸 West Bloomfield, Michigan, United States

NYU Medical Center (Implanting Physician); 🇺🇸 New York, New York, United States

Mercy Pain Management -Surgery Center (Implanting Physician); 🇺🇸 Springfield, Missouri, United States

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

Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician); 🇺🇸 Shreveport, Louisiana, United States

Clinvest Research, LLC (Headache Physician); 🇺🇸 Springfield, Missouri, United States

Henry Ford Hospital (Headache Physician); 🇺🇸 Detroit, Michigan, United States

Montefiore Headache Center (Headache Physician); 🇺🇸 Bronx, New York, United States