Treatment for Migraines With an Implantable Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286078
Recruitment Status : Active, not recruiting
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Boston Scientific Corporation

February 1, 2006
February 3, 2006
April 6, 2016
August 9, 2016
February 8, 2018
February 2006
April 2009   (Final data collection date for primary outcome measure)
  • Migraine Frequency at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in migraine days/month at 12 weeks
  • Frequency of Adverse Event [ Time Frame: 26 weeks ]
    Cumulative frequency of adverse events from randomization to 26 weeks
  • Migraine Frequency at 12 Weeks
  • Frequency of Adverse Event throughout the study.
Complete list of historical versions of study NCT00286078 on Archive Site
Not Provided
  • Migraine Frequency at 26, 40, and 52 weeks
  • Medication use at 12, 26, 40, and 52 weeks
  • Headache Frequency at 12, 26, 40, and 52 weeks
  • Cost-effectiveness, Quality of Life, Disability, and Productivity at 12, 26, 40, and 52 weeks.
Not Provided
Not Provided
Treatment for Migraines With an Implantable Device
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Device: Precision
Implantable neurostimulator
  • Experimental: 1
    Stimulation on
    Intervention: Device: Precision
  • Sham Comparator: 2
    Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
    Intervention: Device: Precision
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2018
April 2009   (Final data collection date for primary outcome measure)

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.


  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Richard Lipton, MD Albert Einstein College of Medicine, Inc.
Boston Scientific Corporation
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP