Treatment for Migraines With an Implantable Device - Full Text View

Purpose

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	Intervention	Phase
Migraine	Device: Precision	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
Official Title:	Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine

Resource links provided by NLM:

MedlinePlus related topics: Migraine

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Migraine Frequency at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
Change from baseline in migraine days/month at 12 weeks
Frequency of Adverse Event [ Time Frame: 26 weeks ]
Cumulative frequency of adverse events from randomization to 26 weeks


Enrollment:	179
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2018
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Stimulation on	Device: Precision Implantable neurostimulator
Sham Comparator: 2 Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.	Device: Precision Implantable neurostimulator

Eligibility


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

Criteria

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.

Exclusion:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286078

Locations


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


Principal Investigator:	Richard Lipton, MD	Albert Einstein College of Medicine, Inc.

More Information


Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00286078 History of Changes
Other Study ID Numbers:	EI0105
Study First Received:	February 1, 2006
Results First Received:	April 6, 2016
Last Updated:	January 30, 2017

Keywords provided by Boston Scientific Corporation:


Headache Migraine Refractory Chronic Pain

Additional relevant MeSH terms:


Migraine Disorders Headache Disorders, Primary Headache Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on July 18, 2017