A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine

Boston Scientific Corporation1 site in 1 country11 target enrollmentMay 2006

ConditionsMigraine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Migraine
Sponsor: Boston Scientific Corporation
Enrollment: 11
Locations: 1
Primary Endpoint: Number of Hours of Headache
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

May 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility 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 fo 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 Criteria

•Have onset of headache after age 50;
•Are current substance abusers (including alcohol and illicit drugs);
•Have a significant psychiatric disorder;
•Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
•Have had nerve stimulation for pain relief.
•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 radiofrequency procedure currently in effect.
•Have a condition currently requiring or likely to require the use of MRI or diathermy;
•Have an active implantable device;
•Are pregnant or lactating or planning to become pregnant in the next 14 months;