Treatment for Migraines With an Implantable Device

Boston Scientific

Status

Completed

Conditions

Migraine

Treatments

Device: Precision

Study type

Interventional

Funder types

Industry

Identifiers

NCT00286078

EI0105

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.