Treatment for Migraines With an Implantable Device
CompletedNot applicableNCT00286078
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
- Conditions
- Interventions
- Sponsor
- Boston Scientific Corporation
- Start date
- 2006-02
- Primary completion
- 2009-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 15
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00286078