Treatment for Migraines With an Implantable Device
July 22, 2019 updated by: Boston Scientific Corporation
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
179
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80218
- Mile High Research Center
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Connecticut
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Stamford, Connecticut, United States, 06902
- The New England Center for Headache
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Georgia
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Augusta, Georgia, United States, 30901
- Walton Rehabilitation Hospital
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Illinois
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Chicago, Illinois, United States, 60614
- Diamond Headache Clinic
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Chicago, Illinois, United States, 60612
- Rush Pain Center
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Massachusetts
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Worcester, Massachusetts, United States, 01605
- New England Regional Headache Center
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Missouri
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Springfield, Missouri, United States, 65807
- Headache Care Center
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Nevada
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Las Vegas, Nevada, United States, 89109
- Headache Specialists
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College of Medicine - Montefiore Headache Unit
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Oregon
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Portland, Oregon, United States, 97210
- The Neurological Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University - Jefferson Headache
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Tennessee
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Nashville, Tennessee, United States, 37203
- Nashville Neuroscience Group
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Texas
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Fort Worth, Texas, United States, 76162
- Research Center
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Utah
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Salt Lake City, Utah, United States, 84106
- Lifetree Clinical Research
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Washington
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Seattle, Washington, United States, 98104
- Swedish Pain & Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment
Active occipital nerve stimulation (stimulation on)
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Implantable neurostimulator
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Sham Comparator: Control
Sham occipital nerve stimulation from activation to 12 weeks post-activation.
Active occipital nerve stimulation from 12 weeks post-activation on.
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Implantable neurostimulator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Migraine Frequency at 12 Weeks
Time Frame: Baseline and 12 weeks
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Change from baseline in migraine days/month at 12 weeks
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Baseline and 12 weeks
|
|
Frequency of Adverse Event
Time Frame: 26 weeks
|
Cumulative frequency of adverse events from randomization to 26 weeks
|
26 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Lipton, MD, Albert Einstein College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
November 7, 2018
Study Registration Dates
First Submitted
February 1, 2006
First Submitted That Met QC Criteria
February 1, 2006
First Posted (Estimate)
February 3, 2006
Study Record Updates
Last Update Posted (Actual)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EI0105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.