Treatment for Migraines With an Implantable Device

Migraine Clinical Trial

Official title:

Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286078
• Other study ID #: EI0105
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: November 7, 2018

Study information

• Verified date: July 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 migraine and alternative therapies are needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: November 7, 2018
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Precision
Implantable neurostimulator

Locations

Country	Name	City	State
United States	Walton Rehabilitation Hospital	Augusta	Georgia
United States	Albert Einstein College of Medicine - Montefiore Headache Unit	Bronx	New York
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Rush Pain Center	Chicago	Illinois
United States	Mile High Research Center	Denver	Colorado
United States	Research Center	Fort Worth	Texas
United States	Headache Specialists	Las Vegas	Nevada
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	Thomas Jefferson University - Jefferson Headache	Philadelphia	Pennsylvania
United States	The Neurological Clinic	Portland	Oregon
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Swedish Pain & Headache Center	Seattle	Washington
United States	Headache Care Center	Springfield	Missouri
United States	The New England Center for Headache	Stamford	Connecticut
United States	New England Regional Headache Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Frequency at 12 Weeks	Change from baseline in migraine days/month at 12 weeks	Baseline and 12 weeks
Primary	Frequency of Adverse Event	Cumulative frequency of adverse events from randomization to 26 weeks	26 weeks