Status:
COMPLETED
Treatment for Migraines With an Implantable Device
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
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 migr...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00286078
Start Date
February 1 2006
End Date
November 7 2018
Last Update
July 30 2019
Active Locations (15)
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1
Mile High Research Center
Denver, Colorado, United States, 80218
2
The New England Center for Headache
Stamford, Connecticut, United States, 06902
3
Walton Rehabilitation Hospital
Augusta, Georgia, United States, 30901
4
Rush Pain Center
Chicago, Illinois, United States, 60612