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

Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE

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.

Study Overview

• Status: Terminated
• Conditions: Migraine Disorders
• Intervention / Treatment: Device: Occipital nerve stimulator

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Valencia, California, United States, 91355
      • Boston Scientific Clinical Research Information Toll Free Number
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago (Implanting Physician)
    • Chicago, Illinois, United States, 60642
      • Diamond Headache Clinic (Headache Physician)
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital (Headache Physician)
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Medical Group (Implanting Physician)
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Pain Management -Surgery Center (Implanting Physician)
    • Springfield, Missouri, United States, 65807
      • Clinvest Research, LLC (Headache Physician)
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Headache Center (Headache Physician)
    • New York, New York, United States, 10016
      • NYU Medical Center (Implanting Physician)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Boston Scientific Precision System

What is the study measuring?

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 intensityOR; 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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Richard Lipton, MD, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: pain; chronic; headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: G120051; CDM00046436 (Other Identifier: BSC protocol number)