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Study of Occipital Nerve Stimulation for Drug Refractory Migraine (PRISM UK)

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: NCT00747812
Recruitment Status : Terminated (Sponsor closed enrollment early based on interim data from the PRISM US Pivotal Study.)
First Posted : September 5, 2008
Results First Posted : August 3, 2012
Last Update Posted : November 27, 2020
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Condition or disease Intervention/treatment Phase
Migraine Device: Precision Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
Study Start Date : May 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: 1
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
Device: Precision
Implantable Neurostimulator

Sham Comparator: 2
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
Device: Precision
Implantable Neurostimulator

Primary Outcome Measures :
  1. Number of Hours of Headache [ Time Frame: 12 weeks ]
  2. Number of Days With 4 or More Hours of Headache [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 fo 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 Criteria:

  • Have onset of headache after age 50;
  • Are current substance abusers (including alcohol and illicit drugs);
  • Have a significant psychiatric disorder;
  • Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
  • Have had nerve stimulation for pain relief.
  • 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 radiofrequency procedure currently in effect.
  • Have a condition currently requiring or likely to require the use of MRI or diathermy;
  • Have an active implantable device;
  • Are pregnant or lactating or planning to become pregnant in the next 14 months;
  • Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747812

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United Kingdom
Royal Free Hospital - Dept of Clinical Neurosciences
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Peter J. Goadsby, MD Royal Free Hospital NHS Foundation Trust
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Responsible Party: Boston Scientific Corporation Identifier: NCT00747812    
Other Study ID Numbers: PRISM-UK-05
First Posted: September 5, 2008    Key Record Dates
Results First Posted: August 3, 2012
Last Update Posted: November 27, 2020
Last Verified: November 2020
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases