Back to resultsTreatment for Migraines With an Implantable Device
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Headache, Migraine, Refractory, Chronic, Pain
Eligibility 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.
Sites / Locations
- Mile High Research Center
- The New England Center for Headache
- Walton Rehabilitation Hospital
- Rush Pain Center
- Diamond Headache Clinic
- New England Regional Headache Center
- Headache Care Center
- Headache Specialists
- Albert Einstein College of Medicine - Montefiore Headache Unit
- The Neurological Clinic
- Thomas Jefferson University - Jefferson Headache
- Nashville Neuroscience Group
- Research Center
- Lifetree Clinical Research
- Swedish Pain & Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control
Arm Description
Active occipital nerve stimulation (stimulation on)
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Outcomes
Primary Outcome Measures
Migraine Frequency at 12 Weeks
Change from baseline in migraine days/month at 12 weeks
Frequency of Adverse Event
Cumulative frequency of adverse events from randomization to 26 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT00286078
First Posted
February 1, 2006
Last Updated
July 22, 2019
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00286078
Brief Title
Treatment for Migraines With an Implantable Device
Official Title
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
November 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Headache, Migraine, Refractory, Chronic, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active occipital nerve stimulation (stimulation on)
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Intervention Type
Device
Intervention Name(s)
Precision
Intervention Description
Implantable neurostimulator
Primary Outcome Measure Information:
Title
Migraine Frequency at 12 Weeks
Description
Change from baseline in migraine days/month at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Frequency of Adverse Event
Description
Cumulative frequency of adverse events from randomization to 26 weeks
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lipton, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
The New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Walton Rehabilitation Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Rush Pain Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
New England Regional Headache Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Headache Care Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Headache Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Albert Einstein College of Medicine - Montefiore Headache Unit
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
The Neurological Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Thomas Jefferson University - Jefferson Headache
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76162
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Swedish Pain & Headache Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment for Migraines With an Implantable Device
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