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Treatment for Migraines With an Implantable Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286078
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Condition or disease Intervention/treatment Phase
Migraine Device: Precision Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
Study Start Date : February 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Active occipital nerve stimulation (stimulation on)
 Device: Precision
Implantable neurostimulator
Sham Comparator: Control
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
 Device: Precision
Implantable neurostimulator


Outcome Measures
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Primary Outcome Measures :
  1. Migraine Frequency at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in migraine days/month at 12 weeks

  2. Frequency of Adverse Event [ Time Frame: 26 weeks ]
    Cumulative frequency of adverse events from randomization to 26 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Be diagnosed with multiple migraines per month of moderate to severe intensity;
  • Be refractory to medication;
  • Be an appropriate candidate for the surgical procedures required for this study;
  • Be willing and able to comply with all study related procedures;
  • Be capable of reading and understanding patient information materials and giving written informed consent.

Key Exclusion Criteria:

  • Have onset of migraine after age 50;
  • Have a significant psychiatric disorder;
  • Have previously been treated with occipital nerve stimulation;
  • Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
  • Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;
  • Have a condition currently requiring or likely to require the use of MRI or diathermy;
  • Have an active implantable device;
  • Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.
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): NCT00286078


Locations
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United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
The New England Center for Headache
Stamford, Connecticut, United States, 06902
United States, Georgia
Walton Rehabilitation Hospital
Augusta, Georgia, United States, 30901
United States, Illinois
Rush Pain Center
Chicago, Illinois, United States, 60612
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Massachusetts
New England Regional Headache Center
Worcester, Massachusetts, United States, 01605
United States, Missouri
Headache Care Center
Springfield, Missouri, United States, 65807
United States, Nevada
Headache Specialists
Las Vegas, Nevada, United States, 89109
United States, New York
Albert Einstein College of Medicine - Montefiore Headache Unit
Bronx, New York, United States, 10461
United States, Oregon
The Neurological Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Thomas Jefferson University - Jefferson Headache
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville Neuroscience Group
Nashville, Tennessee, United States, 37203
United States, Texas
Research Center
Fort Worth, Texas, United States, 76162
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Washington
Swedish Pain & Headache Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Richard Lipton, MD Albert Einstein College of Medicine
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00286078    
Other Study ID Numbers: EI0105
First Posted: February 3, 2006    Key Record Dates
Results First Posted: August 9, 2016
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Boston Scientific Corporation:
Headache
Migraine
Refractory
Chronic
Pain
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases