Treatment for Migraines With an Implantable Device

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00286078
First received: February 1, 2006
Last updated: December 3, 2015
Last verified: December 2015

February 1, 2006
December 3, 2015
February 2006
April 2009   (final data collection date for primary outcome measure)
  • Migraine Frequency at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in migraine days/month at 12 weeks
  • Frequency of Adverse Event. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Cumulative frequency of adverse events an events per subject 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 ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
179
December 2016
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.

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286078
EI0105
No
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Richard Lipton, MD Albert Einstein College of Medicine of Yeshiva University
Boston Scientific Corporation
December 2015

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