Treatment for Migraines With an Implantable Device
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
1 other identifier
interventional
179
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2006
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2006
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedResults Posted
Study results publicly available
August 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2018
CompletedJuly 30, 2019
July 1, 2019
3.2 years
February 1, 2006
April 6, 2016
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Migraine Frequency at 12 Weeks
Change from baseline in migraine days/month at 12 weeks
Baseline and 12 weeks
Frequency of Adverse Event
Cumulative frequency of adverse events from randomization to 26 weeks
26 weeks
Study Arms (2)
Treatment
EXPERIMENTALActive occipital nerve stimulation (stimulation on)
Control
SHAM COMPARATORSham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Mile High Research Center
Denver, Colorado, 80218, United States
The New England Center for Headache
Stamford, Connecticut, 06902, United States
Walton Rehabilitation Hospital
Augusta, Georgia, 30901, United States
Rush Pain Center
Chicago, Illinois, 60612, United States
Diamond Headache Clinic
Chicago, Illinois, 60614, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Headache Care Center
Springfield, Missouri, 65807, United States
Headache Specialists
Las Vegas, Nevada, 89109, United States
Albert Einstein College of Medicine - Montefiore Headache Unit
The Bronx, New York, 10461, United States
The Neurological Clinic
Portland, Oregon, 97210, United States
Thomas Jefferson University - Jefferson Headache
Philadelphia, Pennsylvania, 19107, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Research Center
Fort Worth, Texas, 76162, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Swedish Pain & Headache Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Information
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lipton, MD
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2006
First Posted
February 3, 2006
Study Start
February 1, 2006
Primary Completion
April 1, 2009
Study Completion
November 7, 2018
Last Updated
July 30, 2019
Results First Posted
August 9, 2016
Record last verified: 2019-07