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Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

NCT ID: NCT01775735

Last Updated: 2020-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-10

Study Completion Date

2017-01-19

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).

Conditions

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Migraine Disorders

Keywords

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headache pain chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Occipital nerve stimulator

Intervention Type DEVICE

Electrical stimulation of the greater occipital nerve

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

Group Type ACTIVE_COMPARATOR

Occipital nerve stimulator

Intervention Type DEVICE

Electrical stimulation of the greater occipital nerve

Interventions

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Occipital nerve stimulator

Electrical stimulation of the greater occipital nerve

Intervention Type DEVICE

Other Intervention Names

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Boston Scientific Precision System

Eligibility Criteria

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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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lipton, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Boston Scientific Clinical Research Information Toll Free Number

Valencia, California, United States

Site Status

University of Illinois at Chicago (Implanting Physician)

Chicago, Illinois, United States

Site Status

Diamond Headache Clinic (Headache Physician)

Chicago, Illinois, United States

Site Status

Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)

Shreveport, Louisiana, United States

Site Status

Henry Ford Hospital (Headache Physician)

Detroit, Michigan, United States

Site Status

Henry Ford Medical Group (Implanting Physician)

West Bloomfield, Michigan, United States

Site Status

Mercy Pain Management -Surgery Center (Implanting Physician)

Springfield, Missouri, United States

Site Status

Clinvest Research, LLC (Headache Physician)

Springfield, Missouri, United States

Site Status

NYU Medical Center (Implanting Physician)

New York, New York, United States

Site Status

Montefiore Headache Center (Headache Physician)

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CDM00046436

Identifier Type: OTHER

Identifier Source: secondary_id

G120051

Identifier Type: -

Identifier Source: org_study_id