Clinical trial NCT00286078: 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
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Headache
Migraine
Refractory
Chronic
Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-02-03
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Migraine Frequency at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Frequency of Adverse Event
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Stamford
country: United States
facility: The New England Center for Headache
state: Connecticut
city: Augusta
country: United States
facility: Walton Rehabilitation Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush Pain Center
state: Illinois
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Worcester
country: United States
facility: New England Regional Headache Center
state: Massachusetts
city: Springfield
country: United States
facility: Headache Care Center
state: Missouri
city: Las Vegas
country: United States
facility: Headache Specialists
state: Nevada
city: Bronx
country: United States
facility: Albert Einstein College of Medicine - Montefiore Headache Unit
state: New York
city: Portland
country: United States
facility: The Neurological Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Jefferson Headache
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Fort Worth
country: United States
facility: Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Seattle
country: United States
facility: Swedish Pain & Headache Center
state: Washington
Study officials:
affiliation: Albert Einstein College of Medicine
name: Richard Lipton, MD
role: PRINCIPAL_INVESTIGATOR
References: