This trial is active, not recruiting.

Condition migraine
Treatment precision
Phase phase 3
Sponsor Boston Scientific Corporation
Start date February 2006
End date April 2009
Trial size 179 participants
Trial identifier NCT00286078, EI0105


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Stimulation on
Implantable neurostimulator
(Sham Comparator)
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Implantable neurostimulator

Primary Outcomes

Migraine Frequency at 12 weeks
time frame: 12 weeks
Frequency of Adverse Event.
time frame: 26 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
Principal investigator Richard Lipton, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.