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

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

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)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
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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
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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 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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775735


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
More Information
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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    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018

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