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

• ClinicalTrials.gov Identifier: NCT01775735
• Recruitment Status: Terminated
• First Posted: January 25, 2013
• Results First Posted: November 2, 2018
• Last Update Posted: November 13, 2020
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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

• 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

Arms and Interventions

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	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	Device: Occipital nerve stimulator; Electrical stimulation of the greater occipital nerve; Other Name: Boston Scientific Precision System

Outcome Measures

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 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• 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

Locations

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

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Principal Investigator: Richard Lipton, MD; Albert Einstein College of Medicine

More Information

• 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
• Results First Posted: November 2, 2018
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

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