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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.
 
ClinicalTrials.gov Identifier: NCT00286078
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE February 1, 2006
First Posted Date  ICMJE February 3, 2006
Results First Submitted Date  ICMJE April 6, 2016
Results First Posted Date  ICMJE August 9, 2016
Last Update Posted Date July 30, 2019
Study Start Date  ICMJE February 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
  • Migraine Frequency at 12 Weeks
  • Frequency of Adverse Event throughout the study.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment for Migraines With an Implantable Device
Official Title  ICMJE Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Device: Precision
Implantable neurostimulator
Study Arms  ICMJE
  • Experimental: Treatment
    Active occipital nerve stimulation (stimulation on)
    Intervention: Device: Precision
  • Sham Comparator: Control
    Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
    Intervention: Device: Precision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2007)
179
Original Enrollment  ICMJE
 (submitted: February 1, 2006)
180
Actual Study Completion Date  ICMJE November 7, 2018
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286078
Other Study ID Numbers  ICMJE EI0105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Lipton, MD Albert Einstein College of Medicine
PRS Account Boston Scientific Corporation
Verification Date July 2019

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